FDA Approves Truqap (capivasertib) for HR+/HER2- Advanced Breast Cancer with PIK3CA/AKT1/PTEN Alterations

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FDA Published June 2, 2026 Medically reviewed June 2, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider testing for PIK3CA/AKT1/PTEN alterations in HR+/HER2- advanced breast cancer patients progressing on endocrine therapy for potential Truqap eligibility.

The FDA has approved Truqap (capivasertib), a kinase inhibitor, in combination with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer harboring one or more PIK3CA/AKT1/PTEN alterations. The indication covers patients who have progressed on at least one endocrine-based regimen in the metastatic setting or had recurrence on or within 12 months of completing adjuvant therapy. This approval provides a new targeted option for a subset of patients with these specific genetic alterations, which are detected by an FDA-approved test. Clinicians should note that patient selection requires tumor tissue testing for these alterations. The recommended dose is 400 mg orally twice daily for 4 days followed by 3 days off, with dose modifications for adverse reactions such as hyperglycemia and diarrhea.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Capivasertib is a kinase inhibitor. The exact mechanism in this indication is not fully described in the label.

Indication & Patient Population

Truqap, in combination with fulvestrant, is indicated for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Dosing & Administration

The recommended dosage is 400 mg orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off. Continue until disease progression or unacceptable toxicity. Dose reductions for adverse reactions: first reduction to 320 mg twice daily for 4 days on/3 days off; second reduction to 200 mg twice daily for 4 days on/3 days off. For hyperglycemia, withhold or reduce dose based on fasting glucose levels. For diarrhea, withhold until recovery and consider dose reduction. Refer to fulvestrant prescribing information for its dosing. For premenopausal/perimenopausal women, administer an LHRH agonist; consider for men.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Warnings include hyperglycemia (monitor fasting glucose and HbA1C before and during treatment; manage with anti-diabetic medications and dose modifications) and diarrhea (manage with dose modifications). No contraindications listed in label.

Place in Therapy

Truqap provides a targeted therapy option for patients with HR+/HER2- advanced breast cancer harboring PIK3CA/AKT1/PTEN alterations after progression on endocrine therapy. It is used in combination with fulvestrant and requires genetic testing for patient selection.

Study Details

Study typeFda approval

PublishedNov 2023

View Original Abstract ↓

1 INDICATIONS AND USAGE TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1)