# Breast cancer

The EU has approved 61 indications of 27 drugs in breast cancer. 54 of them need a biomarker result: HER2 (26), Hormone receptor (15), BRCA1/2 (4), ESR1 (3), PD-L1 (3), PIK3CA (2) and AKT1/PIK3CA/PTEN (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### AKT1/PIK3CA/PTEN alteration

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Capivasertib](https://oncolabels.com/drugs/capivasertib) (Truqap) | One or more PIK3CA/AKT1/PTEN-alterations, ER-positive, HER2-negative | + fulvestrant | 2nd line, advanced | Recurrence or progression on or after an endocrine-based regimen; In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a LHRH agonist; for men, administration of LHRH agonist according to current clinical practice standards should be considered |

### BRCA1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | + endocrine therapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Advanced | After anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless not suitable; if HR-positive, progressed on or after prior endocrine therapy, or considered unsuitable for endocrine therapy |
| [Talazoparib](https://oncolabels.com/drugs/talazoparib) (Talzenna) | Germline BRCA1/2-mutations, HER2-negative | Monotherapy | Advanced | Previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless not suitable; prior endocrine-based therapy for HR-positive breast cancer unless considered unsuitable |

### ESR1 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Camizestrant](https://oncolabels.com/drugs/camizestrant) (Etcamah) | ESR1 mutation, ER-positive, HER2-negative | + a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) | 1st line, advanced | During first-line endocrine therapy + CDK4/6 inhibitor, before progression; In pre- or peri-menopausal women and in men, should be combined with a LHRH agonist or antagonist |
| [Elacestrant](https://oncolabels.com/drugs/elacestrant) (Orserdu) | ESR1 mutation, ER-positive, HER2-negative | Monotherapy | 2nd line, advanced | After at least one line of endocrine therapy including a CDK 4/6 inhibitor; Postmenopausal women, and men |
| [Imlunestrant](https://oncolabels.com/drugs/imlunestrant) (Inluriyo) | ESR1 mutation, ER-positive, HER2-negative | Monotherapy | 2nd line, advanced | After prior treatment with an endocrine based regimen; In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadjuvant | Locally advanced, inflammatory, or early stage; high risk of recurrence |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Neoadjuvant | Locally advanced, inflammatory, or early stage; high risk of recurrence |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + neoadjuvant chemotherapy | Neoadjuvant | Then adjuvant monotherapy after surgery; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| [Neratinib](https://oncolabels.com/drugs/neratinib) (Nerlynx) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | Monotherapy | Adjuvant, early | After adjuvant trastuzumab-based therapy completed less than one year ago |
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adjuvant, early | High risk of recurrence |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Adjuvant, early | High risk of recurrence |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel and carboplatin | Adjuvant, early | - |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel or docetaxel | Adjuvant, early | After adjuvant chemotherapy with doxorubicin and cyclophosphamide |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) Ambiguous in the label (treatment phase): check the SmPC. |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant | After neoadjuvant Herceptin + chemotherapy and surgical resection; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| [Trastuzumab emtansine](https://oncolabels.com/drugs/trastuzumab-emtansine) (Kadcyla) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes |
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1st line, advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1st line, advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1st line, metastatic | - |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel | 1st line, metastatic | Anthracycline is not suitable |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | + pertuzumab | 1st line, advanced | - |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive | + capecitabine | 2nd line, advanced | Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-negative | + trastuzumab | 2nd line, metastatic | Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After one or more prior anti-HER2-based regimens |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive | Monotherapy | 2nd line, advanced | After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | IHC 1+ or IHC 2+/ISH-negative, HER2-low | Monotherapy | 2nd line, advanced | After prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy |
| [Trastuzumab emtansine](https://oncolabels.com/drugs/trastuzumab-emtansine) (Kadcyla) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 3rd line+, metastatic | After at least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable) |
| [Tucatinib](https://oncolabels.com/drugs/tucatinib) (Tukysa) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3rd line+, advanced | After at least 2 prior anti-HER2 treatment regimens |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + an aromatase inhibitor | Metastatic | Postmenopausal women; not currently intended for chemotherapy |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + aromatase inhibitor | Metastatic | No prior trastuzumab; Postmenopausal |

### Hormone receptor-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Abemaciclib](https://oncolabels.com/drugs/abemaciclib) (Verzenios) | Hormone receptor-positive, HER2-negative | + endocrine therapy | Adjuvant, early | Node-positive; high risk of recurrence; In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |
| [Ribociclib](https://oncolabels.com/drugs/ribociclib) (Kisqali) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor | Adjuvant, early | High risk of recurrence; in pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |
| [Abemaciclib](https://oncolabels.com/drugs/abemaciclib) (Verzenios) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 1st line, advanced | Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| [Fulvestrant](https://oncolabels.com/drugs/fulvestrant) (Faslodex) | Hormone receptor-positive | Monotherapy | 1st line, advanced | No prior endocrine therapy; Postmenopausal women |
| [Ribociclib](https://oncolabels.com/drugs/ribociclib) (Kisqali) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 1st line, advanced | Women; initial endocrine-based therapy; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| [Toremifene](https://oncolabels.com/drugs/toremifene) (Fareston) | Hormone receptor-positive | Monotherapy | 1st line, metastatic | Postmenopausal |
| [Abemaciclib](https://oncolabels.com/drugs/abemaciclib) (Verzenios) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| [Datopotamab deruxtecan](https://oncolabels.com/drugs/datopotamab-deruxtecan) (Datroway) | Hormone receptor-positive, HER2-negative | Monotherapy | 2nd line, advanced | After endocrine therapy and at least one line of chemotherapy in the advanced setting |
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Afinitor) | Hormone receptor-positive, HER2-negative | + exemestane | 2nd line, advanced | Recurrence or progression following a non-steroidal aromatase inhibitor; Postmenopausal women; without symptomatic visceral disease |
| [Fulvestrant](https://oncolabels.com/drugs/fulvestrant) (Faslodex) | Hormone receptor-positive, HER2-negative | + palbociclib | 2nd line, advanced | After prior endocrine therapy; Women; In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a LHRH agonist |
| [Fulvestrant](https://oncolabels.com/drugs/fulvestrant) (Faslodex) | Hormone receptor-positive | Monotherapy | 2nd line, advanced | Disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy; Postmenopausal women |
| [Palbociclib](https://oncolabels.com/drugs/palbociclib) (Ibrance) | Hormone receptor-positive, HER2-negative | + fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |
| [Ribociclib](https://oncolabels.com/drugs/ribociclib) (Kisqali) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| [Sacituzumab govitecan](https://oncolabels.com/drugs/sacituzumab-govitecan) (Trodelvy) | Hormone receptor-positive, HER2-negative | Monotherapy | 3rd line+, advanced | After endocrine-based therapy, and at least two additional systemic therapies in the advanced setting |
| [Palbociclib](https://oncolabels.com/drugs/palbociclib) (Ibrance) | Hormone receptor-positive, HER2-negative | + an aromatase inhibitor | Advanced | In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist |

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 IC ≥ 1% | + nab-paclitaxel | 1st line, advanced | No prior chemotherapy for metastatic disease |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | + chemotherapy | 1st line, advanced | No prior chemotherapy for metastatic disease |
| [Sacituzumab govitecan](https://oncolabels.com/drugs/sacituzumab-govitecan) (Trodelvy) | PD-L1 CPS ≥ 10 | + pembrolizumab | 1st line, advanced | No prior systemic therapy for metastatic disease |

### PIK3CA mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Alpelisib](https://oncolabels.com/drugs/alpelisib) (Piqray) | PIK3CA mutation, HR-positive, HER2-negative | + fulvestrant | 2nd line, advanced | Following an endocrine-based regimen; Postmenopausal women, and men |
| [Inavolisib](https://oncolabels.com/drugs/inavolisib) (Itovebi) | PIK3CA mutation, ER-positive, HER2-negative | + palbociclib and fulvestrant | 2nd line, advanced | After adjuvant endocrine treatment with recurrence on or within 12 months of completion (if previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting, an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and detection of recurrence is required); In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |

### ER/PR/HER2 negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Datopotamab deruxtecan](https://oncolabels.com/drugs/datopotamab-deruxtecan) (Datroway) | Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1st line, advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + chemotherapy | Neoadjuvant | Then adjuvant monotherapy after surgery; Locally advanced or early-stage; high risk of recurrence |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Adjuvant | After neoadjuvant pembrolizumab + chemotherapy and surgical resection; Locally advanced or early-stage; high risk of recurrence |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + capecitabine | 1st line, metastatic | Treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate; excluded if taxane and anthracycline-containing regimens received in the adjuvant setting within the last 12 months Ambiguous in the label (prior therapy): check the SmPC. |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + paclitaxel | 1st line, metastatic | - |
| [Sacituzumab govitecan](https://oncolabels.com/drugs/sacituzumab-govitecan) (Trodelvy) | None | Monotherapy | 1st line, advanced | No prior systemic therapy for metastatic disease; Not candidates for PD-1 or PD-L1 inhibitor therapy |
| [Sacituzumab govitecan](https://oncolabels.com/drugs/sacituzumab-govitecan) (Trodelvy) | None | Monotherapy | 2nd line, advanced | After two or more prior systemic therapies, including at least one of them for advanced disease |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Pembrolizumab** (Keytruda), Triple-negative breast cancer, neoadjuvant: “KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Triple-negative breast cancer, adjuvant: “KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Triple-negative breast cancer, 1st line, advanced: “KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 3rd line+, metastatic: “as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, metastatic: “in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, neoadjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 1st line, advanced: “Enhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Breast cancer, 2nd line, advanced: “Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, neoadjuvant: “the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, adjuvant, early: “the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, 1st line, advanced: “Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Camizestrant** (Etcamah), Breast cancer, 1st line, advanced: “Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Breast cancer, 1st line, metastatic: “Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Breast cancer, 1st line, metastatic: “Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Datopotamab deruxtecan** (Datroway), Triple-negative breast cancer, 1st line, advanced: “Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf)
- **Datopotamab deruxtecan** (Datroway), Breast cancer, 2nd line, advanced: “Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf)
- **Alpelisib** (Piqray), Breast cancer, 2nd line, advanced: “Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 1st line, advanced: “in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 1st line, advanced: “as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 2nd line, advanced: “as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Breast cancer, 3rd line+, advanced: “Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Abemaciclib** (Verzenios), Breast cancer, adjuvant, early: “Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)
- **Abemaciclib** (Verzenios), Breast cancer, 1st line, advanced: “Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)
- **Abemaciclib** (Verzenios), Breast cancer, 2nd line, advanced: “Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf)
- **Ribociclib** (Kisqali), Breast cancer, adjuvant, early: “Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)
- **Ribociclib** (Kisqali), Breast cancer, 1st line, advanced: “Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)
- **Ribociclib** (Kisqali), Breast cancer, 2nd line, advanced: “Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, advanced: “monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Elacestrant** (Orserdu), Breast cancer, 2nd line, advanced: “ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Triple-negative breast cancer, 1st line, advanced: “Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Palbociclib** (Ibrance), Breast cancer, advanced: “IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf)
- **Palbociclib** (Ibrance), Breast cancer, 2nd line, advanced: “IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf)
- **Trastuzumab emtansine** (Kadcyla), Breast cancer, adjuvant, early: “Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf)
- **Trastuzumab emtansine** (Kadcyla), Breast cancer, 2nd line, advanced: “Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf)
- **Fulvestrant** (Faslodex), Breast cancer, 1st line, advanced: “• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- not previously treated with endocrine therapy, or” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)
- **Fulvestrant** (Faslodex), Breast cancer, 2nd line, advanced: “• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- not previously treated with endocrine therapy, or
- with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)
- **Fulvestrant** (Faslodex), Breast cancer, 2nd line, advanced: “• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf)
- **Inavolisib** (Itovebi), Breast cancer, 2nd line, advanced: “Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf)
- **Capivasertib** (Truqap), Breast cancer, 2nd line, advanced: “TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf)
- **Imlunestrant** (Inluriyo), Breast cancer, 2nd line, advanced: “Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, 2nd line, advanced: “in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, 2nd line, metastatic: “in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, metastatic: “in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Tucatinib** (Tukysa), Breast cancer, 3rd line+, advanced: “TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, neoadjuvant: “the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, adjuvant, early: “the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, 1st line, advanced: “Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Talazoparib** (Talzenna), Breast cancer, advanced: “Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf)
- **Neratinib** (Nerlynx), Breast cancer, adjuvant, early: “Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf)
- **Toremifene** (Fareston), Breast cancer, 1st line, metastatic: “First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with estrogen receptor negative tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fareston-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/breast-cancer