# PIK3CA in breast cancer

3 EU-approved indications in breast cancer need a PIK3CA result: alpelisib (2nd line, advanced), inavolisib (2nd line, advanced) and capivasertib (2nd line, advanced).

## 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 |

### 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 |

## Label wording

- **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)
- **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)

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/pik3ca