# AKT1/PIK3CA/PTEN in breast cancer

1 EU-approved indication in breast cancer needs a AKT1/PIK3CA/PTEN result: 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 |

## Label wording

- **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/akt1-pik3ca-pten