MatchMedi
한국어

Options mapped

Breast cancer: options by country

Sourced options by country plus visit-prep questions for breast cancer — subtype, receptor status, stage, and treatment categories.

Options mappedSolid tumorLast checked May 2026

Options by country

Treatments by country

Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.

Breast cancer (HER2-positive)

United States

European Union

  • trastuzumab deruxtecan (Enhertu)[3]EMA-authorised (central marketing authorisation)Unresectable or metastatic HER2-positive breast cancer after one or more prior HER2-targeted treatments · Central EU authorisation only; member-state reimbursement not verified.
  • trastuzumab emtansine (Kadcyla)[4]EMA-authorised (central marketing authorisation)Residual invasive HER2-positive early breast cancer after neoadjuvant therapy; and unresectable locally advanced or metastatic disease after trastuzumab and a taxane · Central EU authorisation only; member-state reimbursement not verified.
  • tucatinib (Tukysa) + trastuzumab + capecitabine[5]EMA-authorised (central marketing authorisation)Locally advanced or metastatic HER2-positive breast cancer after at least two prior anti-HER2 regimens · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

  • trastuzumab emtansine (Kadcyla)[6]NICE-recommended on the NHS (England and Wales)Adjuvant treatment of HER2-positive early breast cancer with residual invasive disease after neoadjuvant taxane-based and HER2-targeted therapy · Recommended with a commercial arrangement (simple discount).
  • tucatinib + trastuzumab + capecitabine[7]NICE-recommended on the NHS (England and Wales)HER2-positive advanced breast cancer after two or more anti-HER2 therapies · Recommended with a patient access scheme (commercial arrangement).

Japan

  • trastuzumab deruxtecan (Enhertu)[8]PMDA-approved (Japan)Unresectable or recurrent HER2-positive breast cancer refractory or intolerant to standard therapy · Japanese-language original label takes precedence; current-label refresh advised.
  • trastuzumab emtansine (Kadcyla; T-DM1)[9]PMDA-approved (Japan)HER2-positive breast cancer with prior trastuzumab and taxane treatment history · Japanese-language original label takes precedence; current-label refresh advised.

Breast cancer (HR-positive, HER2-negative)

United States

European Union

  • ribociclib (Kisqali) + endocrine therapy[13]EMA-authorised (central marketing authorisation)HR-positive, HER2-negative early high-risk adjuvant disease and locally advanced or metastatic disease · Central EU authorisation only; member-state reimbursement not verified.
  • capivasertib (Truqap) + fulvestrant[14]EMA-authorised (central marketing authorisation)ER-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN alterations after recurrence or progression on an endocrine-based regimen · Central EU authorisation only; member-state reimbursement not verified.

United Kingdom

  • ribociclib + an aromatase inhibitor[15]NICE-recommended on the NHS (England and Wales)Adjuvant treatment of HR-positive, HER2-negative early high-risk breast cancer · Recommended with a commercial arrangement.
  • capivasertib (Truqap) + fulvestrant[16]NICE-recommended on the NHS (England and Wales)HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN alterations after a CDK4/6 inhibitor with an aromatase inhibitor · Recommended with a commercial arrangement.

Japan

  • datopotamab deruxtecan (Datroway)[17]PMDA-approved (Japan)Unresectable or recurrent HR-positive, HER2-negative breast cancer after prior chemotherapy · Japanese-language original label takes precedence; current-label refresh advised.

Triple-negative breast cancer

United States

  • sacituzumab govitecan (Trodelvy)[18]FDA-approvedUnresectable locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies, at least one for metastatic disease
  • olaparib (Lynparza)[19]FDA-approvedGermline BRCA-mutated, HER2-negative high-risk early breast cancer after neoadjuvant or adjuvant chemotherapy · Refresh against current Drugs@FDA labeling before patient-facing reuse.

Breast cancer

United States

  • Capivasertib (Truqap) with fulvestrant[12]FDA-approvedOne or more PIK3CA, AKT1, or PTEN alterations detected by an FDA-approved test; After progression on at least one endocrine-based regimen in metastatic disease, or recurrence on or within 12 months of completing adjuvant therapy. · FDA indication is biomarker-defined and test-defined. This entry does not rank against alpelisib/everolimus or other endocrine-targeted options. Confidence/conflicts: High for FDA approval and setting; no conflict found.
  • Datopotamab deruxtecan-dlnk (Datroway)[20]FDA-approvedTriple-negative; PD-1/PD-L1 inhibitor candidacy is the key source-stated access qualifier; TROPION-Breast02 enrolled patients with unresectable or metastatic TNBC who had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer and who were not candidates for PD-1/PD-L1 inhibitor therapy. · FDA approval is specific to PD-1/PD-L1 inhibitor-ineligible adults with unresectable or metastatic TNBC. FDA notes warnings/precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity. Confidence/conflicts: High for U.S. FDA approval and setting; no conflict found.
  • Fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) with pertuzumab[2]FDA-approvedHER2-positive, IHC 3+ or ISH+; First-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. · FDA source includes warnings/precautions and notes the approval was reviewed under Project Orbis; other regulator reviews were ongoing at the time of the notice. This is a U.S. regulatory claim only. Confidence/conflicts: High for U.S. approval and first-line metastatic setting; no conflict found.
  • Fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd), including T-DXd followed by taxane/trastuzumab/pertuzumab (THP) in neoadjuvant use[1]FDA-approvedHER2-positive, IHC 3+ or ISH+; Neoadjuvant Stage II or III HER2-positive early-stage breast cancer; adjuvant residual invasive disease after neoadjuvant trastuzumab/taxane-based treatment. · FDA notes companion diagnostic devices and boxed/warning precautions. The source is U.S.-specific and does not establish access or approval in other countries. Confidence/conflicts: High for U.S. early-stage indications; no conflict found.
  • Inavolisib (Itovebi) with palbociclib and fulvestrant[11]FDA-approvedPIK3CA-mutated, detected by an FDA-approved test; Endocrine-resistant locally advanced or metastatic disease after recurrence on or after completing adjuvant endocrine therapy; FDA source states INAVO120 enrolled patients without prior systemic therapy for locally advanced or metastatic disease. · Biomarker testing with an FDA-approved test is part of the approval context. This entry does not provide dosing or individual eligibility guidance. Confidence/conflicts: High for FDA approval and setting; no conflict found.
  • Palliative/supportive local therapy including surgery or radiation for limited symptomatic metastases, and bone-modifying therapy for bone metastases[21]NCI PDQ: standard optionHER2-positive metastatic subtype noted by NCI as a metastatic subgroup with comparatively longer median survival outcomes; Metastatic breast cancer supportive/palliative management and selected limited symptomatic metastases. · This is not a claim that surgery or radiation improves outcomes for every metastatic HER2-positive patient. Local therapy is described for limited symptomatic metastases and should be discussed in context of systemic therapy, symptoms, disease extent, and goals. Confidence/conflicts: High for palliative/supportive categories; no patient-specific recommendation made.
  • Radiation therapy after breast-conserving surgery; postmastectomy radiation for high-risk patients; radiation given with trastuzumab in selected adjuvant contexts[21]NCI PDQ: standard optionHER2-positive context relevant to trastuzumab sequencing/safety caveat; Adjuvant local therapy after breast-conserving surgery; selected high-risk postmastectomy settings; HER2-positive adjuvant trastuzumab sequencing/safety context. · Radiation fields, timing, and omission/de-escalation decisions are individualized. PDQ describes evidence and safety context, not eligibility for a specific radiation plan. Confidence/conflicts: High for radiation category and HER2/trastuzumab safety context; no individualized radiation recommendation made.
  • Surgery as part of local treatment (breast-conserving surgery/lumpectomy or mastectomy, with nodal staging as clinically indicated)[21]NCI PDQ: standard optionHER2 overexpression and/or amplification is a prognostic/predictive factor; Local management for nonmetastatic breast cancer; HER2 status informs systemic treatment selection alongside stage and pathology. · NCI PDQ is not a personalized surgical recommendation and does not specify that every HER2-positive case requires the same operation. Surgical choice depends on stage, anatomy, pathology, response to systemic therapy, patient preferences, and local expertise. Confidence/conflicts: High for surgery as a breast-cancer treatment category and HER2 as a treatment-selection factor; no case-specific recommendation made.
  • adjuvant whole-breast radiation therapy after breast-conserving surgery; postoperative chest wall/regional nodal radiation in selected high-risk postmastectomy contexts[21]NCI PDQ: standard optionHR-positive / HER2-negative context; source describes breast cancer radiation broadly; post-breast-conserving surgery; selected high-risk postmastectomy patients. · NCI PDQ describes radiation timing, dose schedules, and toxicity considerations; it notes some controversies around routine adjuvant radiation in patients with one to three involved nodes without high-risk factors. It is not a patient-specific recommendation. Confidence/conflicts: high for NCI PDQ-described radiation contexts; no source conflict identified.
  • breast-conserving surgery; modified radical mastectomy with or without breast reconstruction[21]NCI PDQ: standard optionHR-positive / HER2-negative considered as molecular status in treatment selection; source describes invasive breast cancer surgery broadly; operable breast cancer; local therapeutic approach for the primary tumor. · NCI PDQ states local approach depends on lesion location and size, imaging, breast size, and the patient's desire to preserve the breast; inflammatory breast cancer is described as a contraindication to breast-conserving therapy regardless of histological subtype. NCI PDQ is an evidence summary, not an insurance or individualized treatment recommendation. Confidence/conflicts: high for NCI PDQ-described surgical option categories; no source conflict identified.
  • breast-conserving surgery; modified radical mastectomy with or without reconstruction[21]NCI PDQ: standard optionHER2 overexpression/amplification; NCI PDQ notes HER2 status influences therapy selection; operable invasive breast cancer; local treatment of the primary tumor with systemic planning informed by HER2 status. · NCI PDQ describes broad breast cancer surgery options, not HER2-positive-exclusive surgical rules. It also states local approach depends on lesion location and size, imaging, breast size, and preference for breast preservation. Confidence/conflicts: high for NCI PDQ-described surgical option categories; no source conflict identified.
  • chemotherapy combined or sequenced with HER2-targeted therapy including trastuzumab-based regimens; HER2-targeted therapy with chemotherapy where indicated[21]NCI PDQ: standard optionHER2-positive; neoadjuvant/adjuvant systemic therapy planning for HER2-positive invasive breast cancer. · NCI PDQ is an evidence summary rather than an insurance or individualized treatment recommendation. Specific drug-label approvals should be checked against FDA notices and labels for the exact regimen. Confidence/conflicts: medium-high; no conflict identified, but regimen-specific FDA labels should be checked for exact drug combinations.
  • endocrine/hormone therapy options including tamoxifen, aromatase inhibitors (anastrozole, letrozole, exemestane), fulvestrant, toremifene, and ovarian suppression where applicable[21]NCI PDQ: standard optionHR-positive; HER2-negative context supported by NCI PDQ for HER2-negative hormone receptor-positive breast cancer; adjuvant after surgery, neoadjuvant before surgery, recurrent/advanced/metastatic HR-positive disease, and preoperative endocrine therapy for postmenopausal hormone receptor-positive breast cancer when chemotherapy is not suitable. · NCI describes broad treatment contexts, not patient-specific eligibility. NCI PDQ notes preoperative endocrine therapy in premenopausal women with hormone-responsive breast cancer remains investigational. Confidence/conflicts: high for NCI-described treatment contexts; no source conflict identified.
  • fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu), followed by taxane, trastuzumab, and pertuzumab in neoadjuvant setting; T-DXd in adjuvant residual-disease setting[1]FDA-approvedHER2-positive by IHC 3+ or ISH+ using FDA-authorized testing context; neoadjuvant stage II or III HER2-positive early breast cancer; adjuvant residual invasive disease after specified neoadjuvant HER2-targeted/taxane therapy. · FDA also approved companion diagnostic devices for identifying HER2-positive patients for T-DXd. The FDA notice states event-free survival and overall survival in the neoadjuvant trial were not statistically controlled or powered. Confidence/conflicts: high for FDA approval notice; no source conflict identified.
  • lumpectomy or mastectomy[22]Standard option (per National Cancer Institute)triple-negative; first treatment for stages I-III TNBC when cancer is small enough to be removed by surgery. · NCI describes general TNBC treatment approaches, not individualized surgical eligibility. Larger tumours may receive neoadjuvant chemotherapy, with possible pembrolizumab, before surgery. Confidence/conflicts: high for NCI treatment-information scope; no conflict identified.
  • pembrolizumab (Keytruda) with chemotherapy; continued pembrolizumab after surgery in early-stage setting[23]FDA-approvedtriple-negative; PD-L1 expression by FDA-approved test for locally recurrent unresectable or metastatic setting; neoadjuvant plus adjuvant high-risk early-stage TNBC; locally recurrent unresectable or metastatic TNBC with PD-L1 expression by FDA-approved test. · FDA page is an approval summary, not individualized eligibility. It notes trial data for KEYNOTE-522 and common adverse reactions; full prescribing information and testing requirements should be checked for exact use. Confidence/conflicts: high for FDA approval summary; no source conflict identified.
  • posttherapy surveillance with physical examination and annual mammography for asymptomatic patients after primary treatment[21]NCI PDQ: standard optionHR-positive / HER2-negative; source describes stages I-III breast cancer surveillance broadly; posttherapy surveillance after completion of primary treatment for stage I, II, or III breast cancer in asymptomatic patients. · This is surveillance/supportive-care information after primary treatment, not active anticancer treatment. NCI PDQ states the frequency of follow-up and appropriateness of screening tests remain controversial. Confidence/conflicts: high for NCI PDQ-described posttherapy surveillance summary; no source conflict identified.
  • preoperative endocrine therapy with aromatase inhibitors or tamoxifen in selected contexts[21]NCI PDQ: standard optionHER2-negative; hormone receptor-positive; preoperative/neoadjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer when chemotherapy is not suitable. · NCI PDQ states pCR rates with preoperative hormonal therapy over 3 to 6 months are far lower than chemotherapy in unselected populations, and that longer duration may be required. It also states preoperative endocrine therapy in premenopausal women remains investigational. Confidence/conflicts: high for NCI PDQ-described option and caveats; no source conflict identified.
  • radiation therapy[22]Standard option (per National Cancer Institute)triple-negative; after surgery for TNBC when cancer is found in or near lymph nodes or the tumour margin. · NCI frames radiation as one of several possible post-surgery treatments. It does not state that every TNBC patient receives radiation. Confidence/conflicts: high for NCI treatment-information scope; no conflict identified.
  • ribociclib (Kisqali) with an aromatase inhibitor; ribociclib and letrozole co-pack (Kisqali Femara Co-Pack)[10]FDA-approvedHR-positive / HER2-negative; adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. · FDA source describes the NATALEE trial population and states overall survival was immature at the final invasive disease-free survival analysis. This cell does not address metastatic HR+/HER2- approvals.
  • symptom-directed surgery or radiation therapy, including radiation to painful or uncomfortable areas[22]Standard option (per National Cancer Institute)triple-negative; metastatic stage IV TNBC or recurrent disease in distant or local sites; symptom management and quality-of-life focus. · These are symptom-directed options to discuss, not curative claims or automatic eligibility. Local recurrence in breast or nearby lymph nodes may also be approached with surgery and radiation to remove or shrink tumour. Confidence/conflicts: high for NCI treatment-information scope; no conflict identified.
  • trastuzumab deruxtecan (Enhertu) plus pertuzumab (Perjeta)[24]FDA-approvedHER2-positive by IHC 3+ or ISH+ as determined by FDA-approved test in source language; first-line treatment for unresectable or metastatic HER2-positive breast cancer. · This fetched source is a company regulatory news release rather than an FDA page. It states separate regulatory applications were under review in other countries at the time of publication; this finding records U.S. status only. Confidence/conflicts: medium-high; no conflict identified, but FDA primary page for this specific first-line metastatic approval was not fetched this cycle.
  • whole-breast radiation after breast-conserving surgery; postoperative chest wall/regional nodal radiation in selected high-risk postmastectomy contexts[21]NCI PDQ: standard optionHER2-positive context; radiation recommendations are broadly based on surgery/nodal/margin risk factors; post-breast-conserving surgery; selected high-risk postmastectomy patients. · Radiation decisions are not HER2-positive-specific in the fetched NCI PDQ text and depend on surgical approach, nodal involvement, margins, tumor size, and other risk factors. NCI PDQ also describes acute and late toxicity considerations. Confidence/conflicts: high for NCI PDQ-described radiation contexts; no source conflict identified.

European Union

  • Capivasertib (Truqap) with fulvestrant[14]EMA authorisedOne or more PIK3CA, AKT1, or PTEN alterations; Following recurrence or progression on or after an endocrine-based regimen. · EMA central authorisation does not establish member-state reimbursement or access. EMA notes additional monitoring and separate member-state implementation remains to verify. Confidence/conflicts: High for EU central authorisation; member-state reimbursement source-pending. No conflict found.
  • Capivasertib (Truqap) with fulvestrant[25]ApprovedOne or more PIK3CA, AKT1, or PTEN alterations; Following recurrence or progression on or after endocrine-based therapy in the MA indication. · HAS opinion is reimbursement/clinical-benefit context, not individual eligibility. The source contrasts favourable reimbursement with low clinical benefit and no clinical added value. Confidence/conflicts: High for France HAS reimbursement and clinical-benefit context; no conflict found.
  • Capivasertib (Truqap) with fulvestrant[26]ApprovedOne or more PIK3CA, AKT1, or PTEN alterations; Adult ER-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations following recurrence or progression on or after endocrine-based therapy; G-BA subgroup conclusions vary by sex and timing/line context. · The English file is a courtesy translation and the German original is legally binding. G-BA benefit assessment does not by itself establish individual coverage or center access. Confidence/conflicts: High for G-BA assessment context; German original legally binding. No conflict found.
  • Trastuzumab deruxtecan (Enhertu) monotherapy[3]EMA authorisedHER2-positive; After one or more HER2-targeted treatments for metastatic or unresectable HER2-positive breast cancer, as stated by EMA. · EMA central authorisation does not determine member-state reimbursement in Germany, France, or other EU countries. First-line metastatic T-DXd plus pertuzumab EU approval was not verified on the EMA EPAR during this cycle. Confidence/conflicts: High for EMA-listed HER2-positive post-HER2 treatment authorisation; first-line T-DXd plus pertuzumab remains EU source-pending.
  • endocrine therapy plus CDK4/6 inhibitor; ribociclib, abemaciclib, or palbociclib with aromatase inhibitor or fulvestrant according to AGO-described context[27]Standard option (per Breast Care / Karger; AGO Breast Committee update)HR-positive; HER2 low or HER2 negative; ESR1 and PIK3CA testing contexts described by AGO; advanced/metastatic HR-positive/HER2-low or HER2-negative breast cancer; first-line and later-line before prior CDK4/6 inhibitor exposure. · AGO notes treatment decisions should follow biopsy of metastatic sites to confirm endocrine responsiveness. The article is a guideline update, not a regulator approval or reimbursement source. Confidence/conflicts: medium-high; no source conflict identified. Separate EMA/German reimbursement checks remain needed.
  • endocrine-based therapy including tamoxifen, aromatase inhibitor, ovarian function suppression where applicable; selected addition of olaparib, abemaciclib, or ribociclib in high-risk HER2-negative contexts[28]Standard option (per AGO Breast Committee / DGGG / DKG)HR-positive / HER2-negative; germline BRCA1/2 mutation and recurrence-risk factors where specified; adjuvant endocrine-based therapy in premenopausal and postmenopausal patients with HR-positive/HER2-negative early breast cancer. · AGO pathway grades vary by option and risk group; the source does not establish statutory reimbursement for every option. The algorithm notes HER2-negative-only constraints for some targeted additions. Confidence/conflicts: medium-high; no source conflict identified. Reimbursement and current product-label status require separate checks.
  • olaparib (Lynparza)[29]EMA authorisedgermline BRCA1/2 mutation; HER2-negative; adjuvant high-risk early HER2-negative breast cancer after neoadjuvant/adjuvant chemotherapy; locally advanced or metastatic HER2-negative breast cancer after prior anthracycline and taxane unless unsuitable; HR-positive disease has additional endocrine-therapy context. · This is HER2-negative/BRCA-driven breast cancer and not TNBC-exclusive. EMA central authorisation does not establish member-state reimbursement or genetic testing access. Confidence/conflicts: high for EMA central authorisation; no conflict identified. Member-state reimbursement is a gap.
  • olaparib (Lynparza), monotherapy or with endocrine therapy where relevant[30]HAS reimbursement opiniongermline BRCA1/2 mutation; HER2-negative; adjuvant treatment after neoadjuvant or adjuvant chemotherapy for germline BRCA1/2-mutated HER2-negative high-risk early breast cancer. · This biomarker-driven cell is not TNBC-exclusive. HAS notes the treatment pathway context, including Keytruda in stage 2/3 TNBC, should be considered. Confidence/conflicts: high for HAS opinion scope; no conflict identified.
  • olaparib (Lynparza), monotherapy or with endocrine therapy where relevant[31]G-BA benefit assessmentgermline BRCA1/2 mutation; HER2-negative; adjuvant therapy after neoadjuvant or adjuvant chemotherapy. · This biomarker-driven cell is not TNBC-exclusive. The fetched PDF is an English courtesy translation; only the German version is legally binding. Confidence/conflicts: high for G-BA English courtesy translation content; no conflict identified. German original legally binding.
  • palbociclib (Ibrance) with an aromatase inhibitor or with fulvestrant[32]EMA authorisedHR-positive / HER2-negative; locally advanced or metastatic breast cancer; with fulvestrant after prior endocrine therapy. · EMA central authorisation does not establish member-state reimbursement. EMA states pre- or perimenopausal women should receive endocrine therapy with an LHRH agonist. Confidence/conflicts: high for central EU authorisation; no source conflict identified. Member-state reimbursement not assessed.
  • palbociclib (Ibrance) with letrozole or with fulvestrant[33]ApprovedHR-positive / HER2-negative; locally advanced or metastatic HR+/HER2- breast cancer in postmenopausal women; letrozole combination in first-line advanced or late relapse contexts; fulvestrant combination after endocrine therapy or early progression contexts. · Original source is in French and requires human review before patient-facing reuse. HAS states the reimbursement scope is narrower than the marketing authorization and notes lack of robust comparisons between CDK4/6 inhibitors. Confidence/conflicts: medium; no source conflict identified, but source is French-language and needs human translation review before clinical-content reuse. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) plus chemotherapy[34]HAS reimbursement opiniontriple-negative; PD-L1 CPS >=10; first-line locally recurrent unresectable or metastatic TNBC with PD-L1 CPS >=10. · The HAS opinion is a French reimbursement/health technology assessment context, not a universal EU availability claim. The source states the role versus PARP inhibitors in BRCA1/2-mutated tumours remains to be determined. Confidence/conflicts: high for HAS opinion scope; no conflict identified.
  • pembrolizumab (Keytruda) plus chemotherapy[35]G-BA benefit assessmenttriple-negative; PD-L1 CPS >=10; metastatic setting before prior chemotherapy for metastatic disease. · The PDF is an English courtesy translation; only the German version is legally binding. For chemotherapy combinations other than nab-paclitaxel or paclitaxel, the source states no usable data were available for additional-benefit assessment. Confidence/conflicts: high for G-BA English courtesy translation content; no conflict identified. German original legally binding.
  • pembrolizumab (Keytruda) with chemotherapy as neoadjuvant treatment, then pembrolizumab as adjuvant monotherapy after surgery[36]G-BA benefit assessmenttriple-negative; neoadjuvant plus adjuvant therapy for locally advanced or early-stage TNBC at high risk of recurrence. · The fetched PDF is an English courtesy translation; G-BA states only the German version is legally binding. The source separately states that additional benefit is not proven for chemotherapy combinations outside the specified paclitaxel/carboplatin followed by anthracycline/cyclophosphamide backbone. Confidence/conflicts: high for G-BA English courtesy translation content; no conflict identified. German original legally binding.
  • pembrolizumab (Keytruda) with chemotherapy as neoadjuvant treatment, then pembrolizumab monotherapy as adjuvant treatment after surgery[37]HAS reimbursement opiniontriple-negative; neoadjuvant plus adjuvant treatment for locally advanced or high-risk early-stage TNBC. · HAS states Keytruda provides minor clinical added value in this setting. This is French HTA/reimbursement context and should be checked against current local coverage rules. Confidence/conflicts: high for HAS opinion scope; no conflict identified.
  • pembrolizumab (Keytruda) with chemotherapy; continued pembrolizumab monotherapy after surgery in early-stage setting[38]EMA authorisedtriple-negative; PD-L1 CPS >=10 for locally recurrent unresectable or metastatic setting; neoadjuvant/adjuvant high-risk early or locally advanced TNBC; locally recurrent unresectable or metastatic TNBC with PD-L1 CPS >=10 and no prior chemotherapy for metastatic disease. · EMA central authorisation does not establish reimbursement or routine access in Germany, France, or other member states. Local HTA and payer criteria remain separate. Confidence/conflicts: high for EMA central authorisation; no conflict identified. Member-state reimbursement is a gap.
  • ribociclib (Kisqali) with aromatase inhibitor or fulvestrant[13]EMA authorisedHR-positive / HER2-negative; adjuvant early breast cancer at high risk of recurrence; advanced/metastatic initial endocrine-based therapy or after prior endocrine therapy. · EMA central authorisation does not establish Germany/France or other member-state reimbursement. EMA states pre/perimenopausal women or men receiving an aromatase inhibitor in early breast cancer, and pre/perimenopausal women receiving endocrine therapy in advanced disease, should also receive an LHRH agonist. Confidence/conflicts: high for central EU authorisation; no source conflict identified. Member-state reimbursement not assessed.
  • ribociclib (Kisqali) with fulvestrant[39]EMA authorisedHR-positive / HER2-negative; initial endocrine-based therapy or after prior endocrine therapy; postmenopausal women with locally advanced or metastatic disease without short-term life-threatening symptomatic visceral involvement. · HAS notes no data establish the optimal sequence of CDK4/6 inhibitors and no evidence of clinical benefit for further CDK4/6 inhibitor treatment after prior CDK4/6 inhibitor exposure. This is an HTA/reimbursement assessment, not individualized eligibility. Confidence/conflicts: high for HAS-described French HTA position; no source conflict identified.
  • sacituzumab govitecan (Trodelvy)[40]EMA authorisedtriple-negative / HER2-negative; unresectable or metastatic TNBC after two or more prior systemic therapies, including at least one for advanced disease. · EMA central authorisation does not establish national reimbursement or hospital formulary access. Infusion monitoring and risk-management details are in the package leaflet/product information. Confidence/conflicts: high for EMA central authorisation; no conflict identified. Member-state reimbursement is a gap.
  • sacituzumab govitecan (Trodelvy)[41]HAS reimbursement opiniontriple-negative; after two or more prior systemic therapies, at least one for advanced disease. · HAS notes the place of sacituzumab govitecan in PD-L1-expressing tumours remained to be defined considering the recent introduction of first-line pembrolizumab into the pathway. This is a French HTA/reimbursement opinion, not a dosing or eligibility instruction. Confidence/conflicts: high for HAS opinion scope; no conflict identified.
  • sacituzumab govitecan (Trodelvy)[42]G-BA benefit assessmenttriple-negative; after two or more prior systemic therapies, including at least one for advanced disease. · The fetched PDF is an English courtesy translation; only the German version is legally binding. The benefit assessment is not a personalized sequencing recommendation. Confidence/conflicts: high for G-BA English courtesy translation content; no conflict identified. German original legally binding.
  • surgery; neoadjuvant chemotherapy or adjuvant therapy with or without chemotherapy according to risk algorithm[28]Standard option (per AGO Breast Committee / DGGG / DKG)HR-positive / HER2-negative; ER, PgR, HER2, Ki-67, and gene-expression profile used in AGO algorithm; early HR-positive/HER2-negative breast cancer; surgery and neoadjuvant/adjuvant treatment planning. · The AGO source is a German expert guideline algorithm, not an approval label or reimbursement decision. The algorithm uses risk factors and AGO grades; it is not patient-specific eligibility guidance. Confidence/conflicts: medium-high; no source conflict identified. Local reimbursement and individual center practice were not assessed.
  • trastuzumab deruxtecan (Enhertu)[43]ApprovedHER2-positive; third-line treatment option following failure of trastuzumab/pertuzumab with a taxane and then trastuzumab emtansine, according to the HAS care-pathway discussion. · HAS stated the opinion was conditional on reevaluation within a maximum of 18 months based on DESTINY-BREAST02 phase 3 results and noted no clinical added value on the data available at the time. This is a French reimbursement/HTA opinion, not a blanket statement of individual access. Confidence/conflicts: medium-high for HAS opinion as fetched; no conflict identified. Current post-reevaluation status remains a follow-up gap.
  • trastuzumab deruxtecan (Enhertu)[44]ApprovedHER2-positive; unresectable or metastatic HER2-positive breast cancer after two or more prior anti-HER2-based therapies. · This is a G-BA benefit-assessment resolution/courtesy translation; the German version is legally binding. It does not replace EMA label wording, German prescribing information, or payer-specific authorization steps. Confidence/conflicts: high for fetched G-BA resolution content; no conflict identified. German original is legally binding.
  • trastuzumab emtansine (Kadcyla; T-DM1)[4]EMA authorisedHER2-positive; adjuvant residual invasive disease after neoadjuvant taxane-based and HER2-targeted therapy; unresectable locally advanced or metastatic disease after trastuzumab and taxane. · EMA central authorisation does not determine reimbursement in Germany, France, or other member states. Prior treatment and recurrence timing are part of the metastatic indication wording. Confidence/conflicts: high for EU central authorisation; no source conflict identified. National reimbursement not assessed.
  • trastuzumab emtansine (Kadcyla; T-DM1)[45]ApprovedHER2-positive; adjuvant treatment after neoadjuvant taxane and anti-HER2 therapy when residual invasive disease remains. · The fetched HAS page is French-language and requires human review before patient-facing reuse. HAS states Kadcyla is an alternative to trastuzumab only in the residual invasive disease context after neoadjuvant therapy and says interest is not established in other specified situations. Confidence/conflicts: medium-high for fetched HAS opinion; no conflict identified. French-language wording requires human review. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • trastuzumab emtansine (Kadcyla; T-DM1)[46]ApprovedHER2-positive; adjuvant treatment after neoadjuvant taxane-based and HER2-targeted therapy when residual invasive disease remains. · This is a G-BA benefit-assessment justification/courtesy translation; the German version is legally binding. The document discusses use in a curative adjuvant context and notes adjuvant radiotherapy is not part of the comparator but may be a patient-individual option. Confidence/conflicts: high for fetched G-BA content; no conflict identified. German original is legally binding.
  • tucatinib (Tukysa) in combination with trastuzumab and capecitabine[47]ApprovedHER2-positive; third-line treatment after failure of trastuzumab/pertuzumab with a taxane and then trastuzumab emtansine, according to the HAS care-pathway discussion. · HAS notes the treatment choice should consider efficacy evidence and safety profile, and highlights that trial evidence included patients with brain metastases. This is a reimbursement/HTA opinion rather than individualized eligibility or payer authorization. Confidence/conflicts: high for the fetched HAS reimbursement opinion; no source conflict identified.
  • tucatinib (Tukysa) plus trastuzumab plus capecitabine[48]ApprovedHER2-positive; HER2-positive locally advanced or metastatic breast cancer after at least two prior anti-HER2 treatment regimens. · This is a G-BA benefit-assessment justification/courtesy translation; the German version is legally binding. The document notes no health-related quality-of-life data were collected in HER2CLIMB and classifies reliability of additional-benefit data as a hint. Confidence/conflicts: high for fetched G-BA content; no conflict identified. German original is legally binding.
  • tucatinib (Tukysa) with trastuzumab and capecitabine[5]EMA authorisedHER2-positive; locally advanced or metastatic HER2-positive breast cancer after at least two prior anti-HER2 regimens. · EMA central authorisation does not establish member-state reimbursement. The source describes use with trastuzumab and capecitabine after prior anti-HER2 regimens. Confidence/conflicts: high for EU central authorisation; no source conflict identified. National reimbursement not assessed.

United Kingdom

  • Capivasertib (Truqap) with fulvestrant[16]NICE recommendedOne or more PIK3CA, AKT1, or PTEN gene alterations; After recurrence or progression following a CDK4/6 inhibitor plus an aromatase inhibitor. · NICE scope is narrower than the full licence and applies to NHS England context; it does not establish access in Scotland, Wales implementation details, Northern Ireland, or private care. Confidence/conflicts: High for NICE recommendation; no conflict found, but scope differs from FDA/EMA labels.
  • lymphoedema risk education and specialist lymphoedema referral; written care plan and annual mammography follow-up[49]NICE recommendedHR-positive / HER2-negative where endocrine therapy and breast-cancer treatment side effects apply; source covers breast cancer broadly; treatment side-effect management and follow-up after breast cancer treatment. · These are supportive-care and follow-up measures, not active anticancer treatments. NICE follow-up guidance applies across breast cancer subtypes and should be adapted to individual treatment history and local NHS pathway. Confidence/conflicts: high for NICE guideline text; no source conflict identified.
  • mastectomy, or exceptionally breast-conserving surgery, followed by radiotherapy[49]NICE recommendedtriple-negative if ER/PR/HER2 negative; after neoadjuvant chemotherapy for locally advanced or inflammatory breast cancer. · This is broad locally advanced/inflammatory breast cancer guidance; TNBC relevance depends on receptor status and multidisciplinary assessment. Confidence/conflicts: medium-high for TNBC-relevant broad guideline scope; no conflict identified.
  • neoadjuvant chemotherapy where indicated; local treatment planning by breast cancer team[49]NICE recommendedtriple-negative if ER/PR/HER2 negative by local multidisciplinary team guidelines; early and locally advanced breast cancer; TNBC-specific locally advanced technology appraisal pointers. · NG101 is broad breast-cancer guidance, not TNBC-only. TNBC systemic medicine appraisals are handled in separate NICE technology appraisals. Confidence/conflicts: medium-high for TNBC-relevant broad guideline scope; no conflict identified.
  • neoadjuvant chemotherapy where indicated; neoadjuvant endocrine therapy with tamoxifen or an aromatase inhibitor in selected postmenopausal contexts[49]NICE recommendedER-positive / HER2-negative; neoadjuvant/preoperative treatment for ER-positive invasive breast cancer. · NICE states neoadjuvant endocrine therapy may take longer than chemotherapy to shrink a tumor enough for breast-conserving surgery, and that if ineffective the person may proceed to surgery earlier or may still need chemotherapy before or after surgery. The guideline uses ER-positive language; HR+/HER2-negative relevance comes from the NICE ER-positive/HER2-negative comparison table. Confidence/conflicts: high for NICE guideline text; no source conflict identified.
  • neoadjuvant chemotherapy where indicated; pertuzumab plus trastuzumab; adjuvant trastuzumab, pertuzumab plus trastuzumab and chemotherapy, or neratinib in specified contexts[49]NICE recommendedHER2-positive; neoadjuvant and adjuvant treatment of HER2-positive invasive breast cancer. · NICE says biologic therapy should be used with caution in specified cardiac-risk contexts. Technology appraisal commissioning criteria and commercial arrangements may apply to named medicines. Confidence/conflicts: high for NICE guideline text; no source conflict identified.
  • olaparib (Lynparza), alone or with endocrine therapy where relevant[50]Approvedgermline BRCA1 or BRCA2 mutation; HER2-negative; adjuvant after neoadjuvant or adjuvant chemotherapy in germline BRCA1/2-mutated HER2-negative high-risk early breast cancer. · This biomarker-driven cell is not TNBC-exclusive. NICE notes commercial arrangement requirements, and devolved/private access needs separate verification. Confidence/conflicts: high for NICE recommendation in scope; no conflict identified.
  • pembrolizumab (Keytruda) plus paclitaxel or nab-paclitaxel[51]NICE recommendedtriple-negative; PD-L1 CPS >=10 and immune cell staining <1% per NICE recommendation; untreated metastatic chemotherapy setting for locally recurrent unresectable or metastatic TNBC. · NICE states this recommendation is narrower than the marketing authorisation and is an alternative for people who cannot have atezolizumab combination. Commercial arrangement applies. Confidence/conflicts: high for NICE recommendation in scope; no conflict identified.
  • pembrolizumab (Keytruda) with chemotherapy as neoadjuvant treatment, then pembrolizumab alone as adjuvant treatment after surgery[52]Approvedtriple-negative; neoadjuvant and adjuvant treatment around surgery for early high-risk or locally advanced TNBC. · NICE recommends it only if the company provides pembrolizumab according to the commercial arrangement. NICE guidance does not automatically define access in all devolved/private UK contexts. Confidence/conflicts: high for NICE recommendation in scope; no conflict identified. Devolved/private access remains a gap.
  • postmastectomy radiotherapy[49]NICE recommendedtriple-negative if ER/PR/HER2 negative; postmastectomy after neoadjuvant chemotherapy based on nodal status, margins, and T3 features. · This is broad breast-cancer radiotherapy guidance, not TNBC-only. It should be interpreted through local MDT and current UK radiotherapy practice. Confidence/conflicts: medium-high for TNBC-relevant broad guideline scope; no conflict identified.
  • ribociclib (Kisqali) with an aromatase inhibitor[15]ApprovedHR-positive / HER2-negative; adjuvant treatment of HR-positive, HER2-negative early breast cancer at high risk of recurrence. · NICE states the aromatase inhibitor should be combined with an LHRH agonist unless after menopause. NICE guidance applies to NHS England funding context; devolved and private access may differ. Confidence/conflicts: high for NICE recommendation; no source conflict identified.
  • sacituzumab govitecan (Trodelvy)[53]Approvedtriple-negative; after two or more systemic therapies, including at least one for advanced disease. · NICE recommends it only if the company provides sacituzumab govitecan according to the simple discount patient access scheme. NICE noted usual treatment in this setting is chemotherapy. Confidence/conflicts: high for NICE recommendation in scope; no conflict identified.
  • supportive care needs assessment, key worker/continuity mechanisms, cancer-related fatigue assessment and management, and uncontrolled local disease symptom-control planning[54]NICE recommendedtriple-negative if ER/PR/HER2 negative; source section is not biomarker-specific; advanced breast cancer supportive care; uncontrolled local disease and cancer-related fatigue management. · CG81 is broad advanced breast cancer guidance and is not TNBC-specific. It does not select a particular anticancer therapy. Confidence/conflicts: medium-high for broad advanced breast cancer supportive-care scope; no conflict identified.
  • surgery with appropriate systemic therapy; breast-conserving surgery or mastectomy according to margin and clinical context[49]NICE recommendedER-positive; HER2-negative when endocrine/neoadjuvant comparison is discussed; early and locally advanced invasive breast cancer; local management of ER-positive invasive disease. · NICE recommendations apply within the guideline scope and should be implemented with clinical judgement, individual circumstances, needs, and preferences. The source is not limited only to HR+/HER2-negative disease for every surgical recommendation. Confidence/conflicts: high for NICE guideline text; no source conflict identified.
  • trastuzumab emtansine (Kadcyla; T-DM1)[6]NICE recommendedHER2-positive; adjuvant treatment after residual invasive disease following neoadjuvant taxane-based and HER2-targeted therapy. · NICE states a commercial access agreement exists for trastuzumab emtansine. NICE recommendations should be applied with clinical judgement and individual circumstances. Confidence/conflicts: high for NICE TA overview; no source conflict identified.
  • tucatinib (Tukysa) with trastuzumab and capecitabine[7]NICE recommendedHER2-positive; locally advanced or metastatic HER2-positive breast cancer after two or more anti-HER2 treatment therapies. · NICE states a simple discount patient access scheme exists for tucatinib. NICE recommendations should be applied with clinical judgement and individual circumstances. Confidence/conflicts: high for NICE TA overview; no source conflict identified.
  • whole-breast radiotherapy; partial-breast radiotherapy in selected low-risk cases; omission discussion in very-low-risk cases[49]NICE recommendedER-positive / HER2-negative low-risk radiotherapy subgroup explicitly described by NICE; after breast-conserving surgery for invasive breast cancer with clear margins; low-risk and very-low-risk ER-positive/HER2-negative subgroups as described by NICE. · NICE requires benefits and risks to be discussed for partial-breast radiotherapy or omission. The omission subgroup is limited by age, tumor size/stage, nodal status, ER/HER2 status, grade, clear margins, and willingness to take endocrine therapy. Confidence/conflicts: high for NICE guideline text; no source conflict identified.

Japan

  • Capivasertib (Truqap; Japanese product トルカプ) with fulvestrant[55]PMDA-approved (Japan)One or more PIK3CA, AKT1, or PTEN alterations; HR-positive/HER2-negative breast cancer with PIK3CA/AKT1/PTEN alterations after prior endocrine-therapy progression is supported by PMDA-linked review/package-insert materials, but the Japanese-language clinical text needs human review before patient-facing reuse. · The PMDA sources are Japanese-language regulator materials. Do not surface translated eligibility text without human-language review; reimbursement and prescribing-center implementation are separate gaps. Confidence/conflicts: High for existence of PMDA product listing and regulatory materials; no conflict found. Clinical wording is translation/human-review-needed. Primary source is in Japanese. English summary pending human review — confirm exact wording with your care team.
  • Trastuzumab deruxtecan (Enhertu)[56]PMDA-approved (Japan)HER2-positive; Previously treated with chemotherapy; limited to refractory or intolerant to standard treatments, per PMDA English reference translation. · PMDA states the Japanese original takes precedence over the English reference translation. This entry does not verify current reimbursement or later Japan label expansions. Confidence/conflicts: High for PMDA-described Japan approval context; Japanese original legally/clinically controls if inconsistent.
  • breast surgery within multidisciplinary care; breast-conserving surgery, sentinel lymph node biopsy, axillary surgery, and reconstructive options as appropriate[57]Standard option (per National Cancer Center Hospital East)triple-negative if ER/PR/HER2 negative; operable malignant breast disease; preoperative systemic therapy before curative operation or breast-conserving surgery when appropriate. · This is an academic cancer-center practice page, not a national guideline or TNBC-specific treatment algorithm. It documents care capabilities and multidisciplinary practice rather than eligibility. Confidence/conflicts: medium for Japan surgery practice context; no conflict identified. Not TNBC-exclusive.
  • olaparib (Lynparza)[58]PMDA-approved (Japan)BRCA-mutated; HER2-negative; adjuvant BRCA-mutated HER2-negative high recurrent risk breast cancer; germline BRCA-mutated HER2-negative metastatic breast cancer after prior chemotherapy. · This is company regulatory reporting rather than a PMDA primary review or current package insert. It is biomarker-driven and not TNBC-exclusive. Confidence/conflicts: medium for PMDA-attributed company reporting; no conflict identified. PMDA-primary label remains a gap. Availability/reimbursement outside the approving regulator not established.
  • palbociclib (Ibrance) plus tamoxifen[59]PMDA-approved (Japan)HR-positive / HER2-negative; HR+/HER2- advanced or metastatic breast cancer, including premenopausal, perimenopausal, and postmenopausal patients in the PATHWAY trial context. · The fetched source is an academic cancer-center release describing a package-insert revision, not the current full PMDA label. Exact current indication wording and reimbursement should be checked against PMDA/current Japanese label. Confidence/conflicts: medium-high; no conflict identified. PMDA/current label remains a follow-up source.
  • pembrolizumab (Keytruda) with chemotherapy; continued pembrolizumab after surgery in early-stage setting[60]PMDA-approved (Japan)triple-negative; PD-L1 CPS >=10 for locally recurrent unresectable or metastatic setting; neoadjuvant/adjuvant high-risk early-stage TNBC; locally recurrent unresectable or metastatic PD-L1 CPS >=10 TNBC. · The fetched PMDA-hosted PDF is English-language label text and should be reconciled with current Japanese package insert and reimbursement status before patient-facing reuse. Confidence/conflicts: medium-high for PMDA-hosted label content; no conflict identified. Current Japanese original label should be checked.
  • pembrolizumab (Keytruda) with perioperative chemotherapy[61]Standard option (per Japanese Breast Cancer Society)triple-negative; neoadjuvant/adjuvant therapy for triple-negative early breast cancer. · This is a JBCS guideline publication, not a PMDA label or reimbursement rule. The article notes KEYNOTE-522 evaluated neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab. Confidence/conflicts: high for JBCS guideline statement; no conflict identified. PMDA/reimbursement status should be checked separately.
  • platinum-based chemotherapy[61]Standard option (per Japanese Breast Cancer Society)triple-negative; early breast cancer treated with chemotherapy; TNBC-specific clinical question. · This is a guideline recommendation and not a single fixed regimen. The exact regimen, timing, and suitability require oncology team review. Confidence/conflicts: high for JBCS guideline statement; no conflict identified.
  • sacituzumab govitecan (Trodelvy)[62]FDA-approvedtriple-negative; Trop-2 target noted by source; triple-negative breast cancer; the fetched KEGG entry does not provide line-of-therapy wording. · KEGG confirms a Japan drug/approval cross-reference but is not a PMDA label or review report and does not state the full Japanese indication wording. Current PMDA approval details, line of therapy, and reimbursement need primary-source verification. Confidence/conflicts: medium-low for Japan indication details; no conflict identified. PMDA-primary verification remains required.
  • whole breast irradiation after breast-conserving surgery[63]Established standard of caretriple-negative if ER/PR/HER2 negative; postoperative radiation after breast-conserving surgery in stage I-II breast cancer. · The cited recommendation is broad breast-cancer radiation guidance and not TNBC-only. It should be interpreted with local stage, surgery, nodal status, and radiation oncology review. Confidence/conflicts: high for guideline statement; TNBC-specific applicability is indirect. No conflict identified.

Korea

  • Capivasertib (Tirucap / Truqap) with fulvestrant[64]MFDS-approved (Korea)One or more PIK3CA, AKT1, or PTEN alterations; The regulator-attributed report describes use in HR-positive/HER2-negative advanced breast cancer with PIK3CA/AKT1/PTEN alteration context; exact label wording and reimbursement status remain source-pending pending direct MFDS/NEDRUG extraction. · This is a Korean-language news report quoting/attributing MFDS approval, not the direct MFDS product label. Direct MFDS label and national reimbursement status remain gaps. Confidence/conflicts: Medium-high for MFDS-attributed approval; direct MFDS product source still pending. Korean-language content needs human review before patient-facing reuse. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
  • Trastuzumab deruxtecan (Enhertu 100 mg)[65]MFDS-approved (Korea)HER2-positive; After two or more prior anti-HER2-based regimens for unresectable or metastatic HER2-positive breast cancer, as described in the MFDS-attributed report. · Korean-language regulator-attributed news report; direct MFDS/NEDRUG label extraction and reimbursement status remain source-pending. Confidence/conflicts: Medium-high for MFDS-attributed approval; direct MFDS label still pending. Korean clinical text needs human review. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
  • Trastuzumab deruxtecan (Enhertu) with pertuzumab[66]MFDS-approved (Korea)HER2-positive, IHC 3+ or ISH+; First-line treatment of unresectable or metastatic HER2-positive breast cancer with pertuzumab, as described in the report. · This is Korean-language reporting of a company announcement about MFDS approval; direct MFDS label and reimbursement are source-pending. Confidence/conflicts: Medium for approval expansion pending direct MFDS label extraction; no conflicting source found. Korean clinical text needs human review. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) plus chemotherapy[67]Approvedtriple-negative; PD-L1 CPS >=10 per Korea Biomedical Review later context; locally recurrent unresectable or metastatic TNBC; later KBR reporting frames reimbursement expansion as first-line PD-L1-positive TNBC with CPS >=10. · Korea Biomedical Review is secondary reporting, not an MFDS label. A 2024 KBR article reported that Keytruda was approved but not yet reimbursed for TNBC at that time; a later KBR article reported national insurance reimbursement expansion for first-line PD-L1-positive TNBC starting 2026-01-01. Confidence/conflicts: medium for approval/reimbursement status because sources are secondary but Korea-specific and explicit; no direct conflict, but 2024 non-reimbursement status is superseded by 2026 reported reimbursement expansion for first-line PD-L1-positive TNBC.
  • pembrolizumab (Keytruda) with chemotherapy before surgery, then pembrolizumab after surgery[68]MFDS-approved (Korea)triple-negative; neoadjuvant plus adjuvant treatment for high-risk early-stage TNBC. · The fetched source is secondary reporting and also stated that, as of the article date, Keytruda treatment remained not covered by health insurance for Korean TNBC patients. The source notes Korean carboplatin access constraints for early TNBC backbone chemotherapy. Confidence/conflicts: medium for approval/access status because source is secondary; no conflict identified, but current reimbursement should be refreshed through HIRA/MFDS primary sources.
  • ribociclib (Kisqali) with endocrine therapy[69]ApprovedHR-positive / HER2-negative; advanced/metastatic with endocrine therapy; adjuvant stage 2 or 3 early breast cancer at high risk of recurrence. · This is English KBR reporting; MFDS primary label and HIRA reimbursement status were not fetched this cycle. Confidence/conflicts: medium; no conflict identified. MFDS/HIRA primary confirmation remains a follow-up gap.
  • tucatinib (Tukysa) with trastuzumab and capecitabine[70]ApprovedHER2-positive; HER2-positive locally advanced or metastatic breast cancer after at least two anti-HER2 treatments. · This is secondary approval reporting; MFDS primary label and HIRA reimbursement were not fetched this cycle. The source frames the approval as Korea-specific but does not provide full label text. Confidence/conflicts: medium; no source conflict identified. MFDS/HIRA primary confirmation remains a gap.

China

  • Botudutuximab / botu trastuzumab ADC (Chinese name 注射用博度曲妥珠单抗; brand 舒泰莱)[71]NMPA-approved (China)HER2-positive; After one or more prior anti-HER2 therapies in unresectable or metastatic HER2-positive adult breast cancer. · NMPA page is Chinese-language and needs human-language review before patient-facing reuse. International generic naming and English transliteration should be verified against an official English label or company source before display. Confidence/conflicts: High for China NMPA approval claim; English generic/brand transliteration has medium confidence pending official English source. Chinese clinical text needs human review. Primary source is in Chinese. English summary pending human review — confirm exact wording with your care team. Availability/reimbursement outside the approving regulator not established.
  • Capivasertib (Truqap; Chinese product 荃科得) with fulvestrant[72]NMPA-approved (China)One or more PIK3CA, AKT1, or PTEN alterations; After progression following at least one endocrine therapy in metastatic disease, or recurrence during/within 12 months after adjuvant therapy, as described by NMPA. · NMPA source is Chinese-language regulator content; patient-facing reuse needs human-language review. Provincial reimbursement and hospital formulary access were not verified in this cycle. Confidence/conflicts: High for NMPA approval claim; no conflict found. Chinese-language clinical content is translation/human-review-needed. Primary source is in Chinese. English summary pending human review — confirm exact wording with your care team.
  • Trastuzumab deruxtecan (Enhertu / 优赫得) followed by taxane, trastuzumab, and pertuzumab (THP)[73]NMPA: conditionally approvedHER2-positive; Neoadjuvant treatment for adult HER2-positive Stage II high-risk or Stage III breast cancer. · Xinhua source is Chinese-language; patient-facing translated wording needs human review. The company source notes continued approval in China may be contingent on verification and description of clinical benefit in a confirmatory trial. Confidence/conflicts: Medium-high for China conditional approval; direct NMPA label source remains a gap. Chinese clinical text needs human review. based on a company press release — confirm against the regulator label Primary source is in Chinese. English summary pending human review — confirm exact wording with your care team.
  • bireociclib (Xuanyuening) monotherapy or with fulvestrant[74]NMPA-approved (China)HR-positive / HER2-negative; later-line locally advanced/metastatic HR+/HER2- breast cancer as monotherapy; advanced/metastatic after prior endocrine therapy with fulvestrant. · This is secondary NMPA-attributed medical news citing a company release; NMPA primary label/approval notice and reimbursement status were not fetched this cycle. Confidence/conflicts: medium; no conflict identified. NMPA primary confirmation remains a follow-up gap.
  • pyrotinib plus capecitabine[75]ApprovedHER2-positive; HER2-positive advanced or metastatic breast cancer after anthracycline or taxane chemotherapy. · This is secondary reporting and trial-summary context, not an NMPA primary label. It also notes the drug is not approved for use in the United States. Confidence/conflicts: medium; no source conflict identified. NMPA primary confirmation remains a gap. Availability/reimbursement outside the approving regulator not established.
  • sacituzumab govitecan (Trodelvy)[76]Approvedtriple-negative; Trop-2-directed antibody-drug conjugate; after two or more prior systemic therapies, including at least one in the metastatic setting. · This is company NMPA-attributed approval reporting rather than an NMPA primary page. The source states planned commercial launch timing from 2022, which should not be assumed current without local access verification. Confidence/conflicts: medium for China approval because the source is explicit but company/PR; no conflict identified. NMPA primary label remains a gap. Availability/reimbursement outside the approving regulator not established.
  • sacituzumab tirumotecan (SKB264/MK-2870; sac-TMT)[77]NMPA-approved (China)triple-negative; TROP2-directed antibody-drug conjugate; second line or later advanced/metastatic TNBC after at least two prior systemic therapies. · This is oncology news citing a Kelun-Biotech release, not a direct NMPA label. The source identifies OptiTROP-Breast01 as support for the regulatory decision. Confidence/conflicts: medium because the source is secondary; no conflict identified. NMPA primary verification remains needed. Availability/reimbursement outside the approving regulator not established.
  • trastuzumab deruxtecan (Enhertu)[78]NMPA-approved (China)HER2-positive; unresectable or metastatic HER2-positive breast cancer after one or more prior anti-HER2-based regimens; source describes this as a second-line option. · This is company regulatory approval reporting, not the NMPA primary label. Reimbursement and hospital access in China were not assessed. Confidence/conflicts: medium-high; no source conflict identified. NMPA primary confirmation remains a gap.
  • trastuzumab deruxtecan (Enhertu) followed by paclitaxel, trastuzumab, and pertuzumab (THP)[79]NMPA: conditionally approvedHER2-positive by IHC 3+ or ISH+; neoadjuvant treatment before surgery for HER2-positive stage 2 high-risk or stage 3 breast cancer. · The source states continued approval may depend on verification and description of clinical benefit in confirmatory studies. This is company regulatory reporting, not an NMPA primary label. Confidence/conflicts: medium-high; no source conflict identified. NMPA primary confirmation remains a gap.

Russia

  • anthracycline- and taxane-containing chemotherapy regimens; docetaxel/cyclophosphamide option in selected small node-negative contexts[80]Standard option (per RUSSCO / rosoncoweb.ru)ER-negative, PR-negative, HER2-negative; adjuvant early triple-negative breast cancer, stratified by tumour size and nodal status. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. This is a guideline statement, not a drug-label or reimbursement verification. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • capecitabine[80]Standard option (per RUSSCO / rosoncoweb.ru)ER-negative, PR-negative, HER2-negative; post-neoadjuvant/adjuvant residual invasive TNBC after standard neoadjuvant anthracycline/taxane chemotherapy. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. The source notes radiotherapy timing context with capecitabine, which needs clinician interpretation and local verification. Confidence/conflicts: medium-high for guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • olaparib[80]Standard option (per RUSSCO / rosoncoweb.ru)BRCA-associated; triple-negative; residual invasive disease criteria in source; adjuvant after standard neoadjuvant chemotherapy in BRCA-associated TNBC with residual invasive disease. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. It does not verify Russian regulator label, reimbursement, genetic testing access, or whether olaparib and capecitabine should be sequenced in a given case. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) plus paclitaxel; or pembrolizumab plus gemcitabine/carboplatin[80]Standard option (per RUSSCO / rosoncoweb.ru)triple-negative; PD-L1 CPS context described by RUSSCO; metastatic TNBC first-line context after progression at least six months after neoadjuvant/adjuvant chemotherapy and PD-L1 CPS >=10 per source footnote. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. MFDS/FDA/EMA-style label language is not provided; Russian regulator label and reimbursement remain unverified. Confidence/conflicts: medium for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review and regulator-primary status is unverified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • trastuzumab emtansine (T-DM1; Kadcyla)[80]Standard option (per RUSSCO / rosoncoweb.ru)HER2-positive; residual disease criteria in source; post-neoadjuvant/adjuvant HER2-positive early breast cancer with residual disease after neoadjuvant systemic therapy. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. It does not establish current Russian regulator approval text, payer rules, or hospital access. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • trastuzumab emtansine (T-DM1; Kadcyla); trastuzumab with alternative chemotherapy partners; lapatinib plus capecitabine or lapatinib plus trastuzumab; trastuzumab deruxtecan (Enhertu)[80]Standard option (per RUSSCO / rosoncoweb.ru)HER2-positive; second line and subsequent lines for HER2-positive metastatic breast cancer; the source includes a CNS-metastasis note for trastuzumab deruxtecan after two or more anti-HER2 lines. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. It does not verify which listed products are currently reimbursed or routinely available in a particular Russian region or center. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • trastuzumab plus pertuzumab plus a taxane; continued trastuzumab/pertuzumab anti-HER2 therapy after taxane chemotherapy in the source algorithm[80]Standard option (per RUSSCO / rosoncoweb.ru)HER2-positive; first-line HER2-positive metastatic breast cancer. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. It is a guideline source, not a regulator label, reimbursement list, or availability guarantee. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • trastuzumab with chemotherapy; trastuzumab plus or minus pertuzumab with chemotherapy in higher-risk node-positive contexts[80]Standard option (per RUSSCO / rosoncoweb.ru)HER2-positive; hormone receptor status may affect endocrine therapy add-on; adjuvant/post-neoadjuvant HER2-positive early breast cancer; RUSSCO separates smaller node-negative tumours from larger/node-positive contexts. · Source is Russian-language professional guidance and needs human review before patient-facing reuse. This entry does not establish Russian regulator label wording, reimbursement, or individual eligibility. Confidence/conflicts: medium-high for source-supported guideline presence; no conflict identified. Russian-language clinical wording requires human review. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

  • ado-trastuzumab emtansine (T-DM1; Kadcyla)[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)HER2-positive; second-line HER2-positive metastatic breast cancer after progression on a taxane and trastuzumab when trastuzumab deruxtecan is not available. · The source does not establish Thai FDA approval wording, reimbursement, or center-level access. The T-DXd/T-DM1 availability status was reported as of March 2023 and may be stale for current access decisions. Confidence/conflicts: medium-high for guideline and table-reported availability; no source conflict identified. Needs Thai regulator/current-label refresh.
  • atezolizumab (Tecentriq) plus nab-paclitaxel[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)ER-negative, PgR-negative, HER2-low/negative TNBC definition in source; PD-L1 immune-cell positivity by Ventana SP142 in the recommendation; PD-L1 immune-cell-positive metastatic TNBC where disease-free interval is at least 12 months, in countries where this indication is approved. · The guideline language is conditional on local indication approval; the availability table is not a Thai FDA label, reimbursement decision, or hospital formulary. Atezolizumab TNBC indications vary by jurisdiction and must be checked locally. Confidence/conflicts: medium for Thailand-specific applicability because table availability is not label verification; no direct conflict in fetched source.
  • lapatinib-based combinations, preferably with capecitabine, trastuzumab, or endocrine therapy where clinically appropriate[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)HER2-positive; later-line HER2-positive metastatic breast cancer. · The source does not provide Thai label wording, reimbursement criteria, or individual treatment sequencing. The same guideline states there is no evidence for sequencing a tyrosine kinase inhibitor after a tyrosine kinase inhibitor in HER2-positive metastatic breast cancer. Confidence/conflicts: medium-high for guideline statement and table-reported Thai availability; no conflict identified. Current Thai label/reimbursement remains a gap.
  • local treatment modalities including surgery or radiotherapy for symptom palliation or prevention of complications[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)HER2-positive if the metastatic breast cancer subtype is HER2-positive; primary stage IV breast cancer with intact primary tumour; symptomatic local disease or prevention of complications. · This is broad metastatic breast cancer guidance rather than HER2-positive-only guidance. It supports discussion of palliative/local-control options, not routine surgery or radiotherapy for all metastatic presentations. Confidence/conflicts: medium-high for the guideline's palliative/local-control recommendation; no source conflict identified. Thai site-level availability of radiotherapy/surgery is not established by this source.
  • olaparib; talazoparib listed as a PARP inhibitor option in the guideline but not available for Thailand in the table[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)germline pathogenic or likely pathogenic BRCA1/2 mutation; HER2-negative; HER2-negative metastatic breast cancer with germline BRCA1/2 pathogenic or likely pathogenic variant; applies across HR status, including TNBC, when clinically relevant. · This cell is biomarker-driven and not TNBC-exclusive. The table provides drug availability, not Thai indication/reimbursement criteria or genetic testing access. Confidence/conflicts: medium-high for guideline and table status; Thai regulator-primary and reimbursement status remain gaps.
  • palbociclib (Ibrance) with an aromatase inhibitor or with fulvestrant[82]FDA-approvedHR-positive / HER2-negative; initial endocrine-based therapy with an aromatase inhibitor; or after prior endocrine therapy with fulvestrant. · Label states pre- or perimenopausal women should receive endocrine therapy with an LHRH agonist. It also states treatment should be initiated and supervised by a physician experienced in anticancer medicinal products and includes blood-count monitoring and ILD/pneumonitis precautions. Confidence/conflicts: high; no source conflict identified. Reimbursement/formulary access was not assessed.
  • pembrolizumab (Keytruda) plus paclitaxel, nab-paclitaxel, or carboplatin-gemcitabine[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)ER-negative, PgR-negative, HER2-low/negative TNBC definition in source; PD-L1 CPS at least 10 in the recommendation; PD-L1 CPS >=10 metastatic TNBC where disease-free interval is at least 6 months. · The table reports availability of pembrolizumab, not Thai TNBC indication wording or reimbursement. Local Thai label, assay requirements, and payer/access criteria need separate verification. Confidence/conflicts: medium-high for guideline support and table availability; Thai regulator-primary verification remains a gap.
  • pertuzumab plus trastuzumab plus docetaxel; possible maintenance pertuzumab-trastuzumab after docetaxel[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)HER2-positive; hormone receptor status considered in the guideline; first-line HER2-positive metastatic breast cancer regardless of hormone receptor status; docetaxel followed by maintenance pertuzumab-trastuzumab if tolerated is described. · This is a Pan-Asian guideline and availability table, not a Thai FDA label, hospital formulary, or reimbursement determination. Local access, product registration, and payer coverage still need Thailand-specific verification. Confidence/conflicts: medium-high for guideline recommendation and table-reported Thai availability; no conflict identified. Thai regulator-primary status remains a separate gap.
  • sacituzumab govitecan[81]Standard option (per ESMO Open / Pan-Asian adapted ESMO guideline authors)TNBC; germline BRCA status may alter sequencing separately; after taxanes in TNBC that has progressed on prior anthracycline and/or taxane therapy. · This is an important negative/availability cell for Thailand: guideline-supported if available, but the same source marks it not available in Thailand as of March 2023. Current access, compassionate use, private import, or later regulatory changes require verification. Confidence/conflicts: medium-high for 2023 guideline/table status; no conflict identified, but current Thai approval/access may have changed.
  • trastuzumab (Trazimera; trastuzumab biosimilar to Herceptin reference product)[83]FDA-approvedHER2 overexpression / HER2-positive tumor status; HER2-positive metastatic breast cancer; HER2-positive early breast cancer following surgery/systemic therapy/radiotherapy context; locally advanced or tumors larger than 2 cm in neoadjuvant-to-adjuvant context. · HER2 testing is mandatory before initiation according to the label. The fetched label establishes Thai registered product information, not reimbursement or hospital formulary access. Confidence/conflicts: high for Thai label indication text; no source conflict identified. Reimbursement/access not assessed.
  • trastuzumab deruxtecan (Enhertu)[84]FDA-approvedHER2-positive tumor status; IHC/ISH/FISH definitions stated in label; unresectable or metastatic HER2-positive breast cancer after at least one prior anti-HER2-based regimen. · The label states patients should have documented HER2-positive tumor status and that Enhertu should not be substituted with trastuzumab or trastuzumab emtansine. The label also includes safety monitoring and dose-modification information that should be reviewed by clinicians; reimbursement/access not assessed. Confidence/conflicts: high for Thai label indication text; no source conflict identified. Reimbursement/access not assessed.

Canada

  • Capivasertib (Truqap) with fulvestrant[85]ApprovedOne or more PIK3CA, AKT1, or PTEN alterations; After at least one endocrine-based regimen in metastatic disease, or recurrence on or within 12 months of completing adjuvant therapy. · CADTH recommendation is not the same as province-by-province implementation. The source states price reduction and feasibility of alteration testing are among reimbursement conditions. Confidence/conflicts: High for CADTH recommendation; provincial implementation source-pending. No conflict found.

Sources

  1. FDA approval notice — Enhertu HER2-positive early-stage breast cancer · regulator approval notice
  2. FDA approval notice — Enhertu plus pertuzumab first-line HER2-positive metastatic breast cancer · regulator approval notice
  3. EMA EPAR — Enhertu (trastuzumab deruxtecan) · regulator EPAR
  4. EMA EPAR — Kadcyla (trastuzumab emtansine) · regulator EPAR
  5. EMA EPAR — Tukysa (tucatinib) · regulator EPAR
  6. NICE TA632 — trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer · health technology appraisal
  7. NICE TA786 — tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer · health technology appraisal
  8. PMDA review report — Enhertu (trastuzumab deruxtecan) · regulator review report
  9. PMDA deliberation report — Kadcyla (trastuzumab emtansine) · regulator review report
  10. FDA approval notice — ribociclib with an aromatase inhibitor, early high-risk breast cancer · regulator approval notice
  11. FDA approval notice — inavolisib with palbociclib and fulvestrant · regulator approval notice
  12. FDA approval notice — capivasertib with fulvestrant for breast cancer · regulator approval notice
  13. EMA EPAR — Kisqali (ribociclib) · regulator EPAR
  14. EMA EPAR — Truqap (capivasertib) · regulator EPAR
  15. NICE TA1086 — ribociclib with an aromatase inhibitor for adjuvant treatment · health technology appraisal
  16. NICE TA1063 — capivasertib with fulvestrant for HR-positive HER2-negative advanced breast cancer · health technology appraisal
  17. PMDA review report — Datroway (datopotamab deruxtecan) · regulator review report
  18. NCI Cancer Currents — sacituzumab govitecan regular FDA approval for TNBC · NCI explainer of FDA approval
  19. FDA label (Drugs@FDA) — Lynparza (olaparib) · official drug label
  20. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  21. National Cancer Institute (NCI) — national cancer agency PDQ health professional summary · national cancer agency PDQ health professional summary
  22. National Cancer Institute (NCI) — national cancer agency treatment information · national cancer agency treatment information
  23. U.S. Food and Drug Administration (FDA) — regulator approval summary · regulator approval summary
  24. AstraZeneca / Daiichi Sankyo — company regulatory approval news release · company regulatory approval news release
  25. Haute Autorite de Sante (HAS) — HTA reimbursement and clinical-benefit opinion · HTA reimbursement and clinical-benefit opinion
  26. Gemeinsamer Bundesausschuss (G-BA) — AMNOG benefit-assessment justification courtesy translation · AMNOG benefit-assessment justification courtesy translation
  27. Breast Care / Karger; AGO Breast Committee update — peer-reviewed guideline update · peer-reviewed guideline update
  28. AGO Breast Committee / DGGG / DKG — national expert guideline algorithm PDF · national expert guideline algorithm PDF
  29. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  30. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  31. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  32. European Medicines Agency — regulator product page / EPAR · regulator product page / EPAR
  33. Haute Autorite de Sante (HAS), hosted by Pfizer France — French HTA/reimbursement opinion PDF · French HTA/reimbursement opinion PDF
  34. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  35. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  36. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  37. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  38. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  39. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion page · health technology assessment / reimbursement opinion page
  40. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  41. Haute Autorite de Sante (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  42. Federal Joint Committee (G-BA) — benefit assessment resolution PDF / courtesy translation · benefit assessment resolution PDF / courtesy translation
  43. Haute Autorité de Santé (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  44. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / courtesy translation PDF · benefit-assessment resolution / courtesy translation PDF
  45. Haute Autorité de Santé (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  46. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment justification / courtesy translation PDF · benefit-assessment justification / courtesy translation PDF
  47. Haute Autorité de Santé (HAS) — health technology assessment / reimbursement opinion · health technology assessment / reimbursement opinion
  48. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment justification / courtesy translation PDF · benefit-assessment justification / courtesy translation PDF
  49. National Institute for Health and Care Excellence (NICE) — national guideline · national guideline
  50. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  51. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  52. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  53. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  54. National Institute for Health and Care Excellence (NICE) — clinical guideline recommendations · clinical guideline recommendations
  55. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator medical product page / package-insert index · regulator medical product page / package-insert index
  56. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report English reference translation · regulator review report English reference translation
  57. National Cancer Center Hospital East — academic cancer-center department page · academic cancer-center department page
  58. Merck / AstraZeneca — company regulatory approval news release · company regulatory approval news release
  59. National Cancer Center Japan — academic cancer-center / package-insert revision announcement · academic cancer-center / package-insert revision announcement
  60. Pharmaceuticals and Medical Devices Agency (PMDA) — PMDA-hosted label document PDF · PMDA-hosted label document PDF
  61. Japanese Breast Cancer Society (JBCS) — clinical practice guideline article PDF · clinical practice guideline article PDF
  62. KEGG DRUG — drug database / Japan drug and approval cross-reference · drug database / Japan drug and approval cross-reference
  63. Japanese Breast Cancer Society / Breast Cancer journal — clinical practice guideline article · clinical practice guideline article
  64. Yonhap News Agency — regulator-attributed news report · regulator-attributed news report
  65. MEDI:GATE News — regulator-attributed news report · regulator-attributed news report
  66. Medifonews — company-announcement news report referencing MFDS approval · company-announcement news report referencing MFDS approval
  67. Korea Biomedical Review — medical news / MFDS-attributed approval report · medical news / MFDS-attributed approval report
  68. Korea Biomedical Review — medical news / MFDS-attributed approval and access report · medical news / MFDS-attributed approval and access report
  69. Korea Biomedical Review — medical news / regulatory approval reporting · medical news / regulatory approval reporting
  70. Lexology / Pearce IP, citing Korea Biomedical Review — regulatory approval alert / secondary reporting · regulatory approval alert / secondary reporting
  71. National Medical Products Administration (NMPA) — regulator approval notice · regulator approval notice
  72. National Medical Products Administration (NMPA) — regulator approval notice · regulator approval notice
  73. Xinhua News — NMPA-attributed health news report · NMPA-attributed health news report
  74. OncLive — medical news / NMPA-attributed approval reporting · medical news / NMPA-attributed approval reporting
  75. Oncology News Central — medical news / China approval and clinical-trial reporting · medical news / China approval and clinical-trial reporting
  76. Everest Medicines via PR Newswire — company regulatory approval news release · company regulatory approval news release
  77. OncLive — oncology news / NMPA-attributed approval report · oncology news / NMPA-attributed approval report
  78. AstraZeneca / Daiichi Sankyo — company regulatory approval news release · company regulatory approval news release
  79. Daiichi Sankyo / AstraZeneca — company regulatory approval news release PDF · company regulatory approval news release PDF
  80. RUSSCO / rosoncoweb.ru — professional society practical recommendations PDF · professional society practical recommendations PDF
  81. ESMO Open / Pan-Asian adapted ESMO guideline authors — peer-reviewed guideline / regional society-endorsed adaptation · peer-reviewed guideline / regional society-endorsed adaptation
  82. Thailand National Drug Information / Thai FDA-MOPH — official product information / label · official product information / label
  83. Thai FDA / Ministry of Public Health National Drug Information — official product label PDF · official product label PDF
  84. Thai FDA / Ministry of Public Health National Drug Information — official product label PDF · official product label PDF
  85. CADTH / Canadian Journal of Health Technologies via NCBI Bookshelf — reimbursement recommendation · reimbursement recommendation

This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Some options shown have accelerated or conditional approval, which can be narrowed or withdrawn — reconfirm at the source. Last checked June 2026.

Beyond approved care

In clinical trials & emerging options

Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.

In clinical trials

A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked June 2026.

What this page does

Maps options by country

It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.

What it does not do

Does not choose treatment

It does not rank treatments, recommend a choice, or decide clinical fit.

Where it comes from

Built on trusted sources

Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.

Why this condition is included

  • Breast cancer decisions often depend on receptor status and treatment sequence.
  • This page helps families collect pathology and receptor details without making treatment claims.
  • Options are mapped carefully because the landscape is broad and changes by subtype; each line links to its source.

Information to gather before the next visit

  • What are the ER, PR, and HER2 results?
  • What stage and grade are documented?
  • Is treatment being discussed before surgery, after surgery, or for metastatic disease?
  • Which treatment categories did the oncology team mention?

Trial-search terms to discuss

breast cancer HER2 clinical trialbreast cancer hormone receptor clinical trial