# Triple-negative breast cancer

The EU has approved 15 indications of 8 drugs in triple-negative breast cancer. 8 of them need a biomarker result: BRCA1/2 (4), PD-L1 (3) and HER2 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### 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 |

### HER2-low

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [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 |

### 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 |

### 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 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)
- **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)
- **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)
- **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)
- **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)
- **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)

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/triple-negative-breast-cancer