# Hormone receptor in breast cancer

26 EU-approved indications in breast cancer need a Hormone receptor result: trastuzumab (metastatic), trastuzumab deruxtecan (2nd line, advanced), everolimus (2nd line, advanced), camizestrant (1st line, advanced), datopotamab deruxtecan (1st line, advanced), datopotamab deruxtecan (2nd line, advanced), alpelisib (2nd line, advanced), sacituzumab govitecan (3rd line+, advanced), abemaciclib (adjuvant, early), abemaciclib (1st line, advanced), abemaciclib (2nd line, advanced), ribociclib (adjuvant, early), ribociclib (1st line, advanced), ribociclib (2nd line, advanced), elacestrant (2nd line, advanced), palbociclib (advanced), palbociclib (2nd line, advanced), fulvestrant (1st line, advanced), fulvestrant (2nd line, advanced), fulvestrant (2nd line, advanced), inavolisib (2nd line, advanced), capivasertib (2nd line, advanced), imlunestrant (2nd line, advanced), lapatinib (metastatic), neratinib (adjuvant, early) and toremifene (1st line, metastatic).

## Approved indications

### Hormone receptor

| 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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |
| [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 |

### 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 |

## Label wording

- **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 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)
- **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)
- **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)
- **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), 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)
- **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)
- **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)
- **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, 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)
- **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/hormone-receptor