VA CFU Criteria Formulary Advisor Reference
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CAPIVASERTIB TAB

Generic Name
CAPIVASERTIB TAB
Brand Names
TRUQAP
Drug Class
ANTINEOPLASTIC,OTHER
Formulary Status
PA-F
Copay Tier
3
Last Updated
2023-11-30

Clinical Criteria Summary

Document 797

Indication & Patient Population

  • Adult patients (pre-, peri-, post-menopausal women or men) with hormone receptor (HR)-positive, HER2-negative, locally advanced (inoperable) or metastatic breast cancer
  • Patients must have one or more PIK3CA/AKT1/PTEN-alterations (activating mutations in PIK3CA and AKT1; inactivating alterations in PTEN)
  • Disease status: Progressive disease on aromatase inhibitors (AI) with or without a CDK4/6 inhibitor in the metastatic setting, or within 12 months of neoadjuvant or adjuvant AI

Dosing & Administration

  • 400 mg orally twice daily, with or without food
  • Schedule: 4 days on followed by 3 days off per 28-day treatment cycle
  • Administered in combination with fulvestrant (500 mg intramuscular injection on cycle 1 days 1 and 15, then day 1 of each subsequent 28-day cycle)

Contraindications

  • Severe hypersensitivity to capivasertib or any of its components

Monitoring & Management Requirements

  • Hyperglycemia: Test fasting blood glucose (FBG) and HbA1C; optimize glucose levels; monitor per prescribing information. Type I diabetes/IDDM patients are excluded.
  • Diarrhea: Monitor for signs and symptoms; initiate anti-diarrheal medication at first indication; manage with dose reductions as needed.
  • Cutaneous adverse reactions: Monitor for signs and symptoms; consider dermatology consultation; corticosteroids (topical or systemic) may be required.
  • Embryo-fetal toxicity precautions apply.
  • Regularly scheduled monitoring and patient/caregiver education are required, particularly for patients with concomitant diabetes or GI conditions.

VA/NCCN Pathway Alignment

  • VA Breast Cancer – Stage IV ER+ or PR+/HER2- pathway directs use in patients who have progressed on prior endocrine therapy and have a molecular alteration identified in AKT-PTEN
  • NCCN Invasive Breast Cancer Guidelines V4.2025 (Category 1) list capivasertib plus fulvestrant as preferred second or subsequent-line therapy for recurrent, unresectable, or metastatic ER+/PR+/HER2- patients with PIK3CA, AKT2, or PTEN alterations who have progressive disease after >1 prior line of endocrine therapy

Document 812

Exclusion Criteria

  • Uncontrolled hyperglycemia
  • Chronic, uncontrolled diarrhea
  • Severe renal impairment (CrCl 15-29 ml/min)
  • Severe hepatic impairment (bilirubin > 3x upper limit of normal and any AST)
  • Unmanageable drug-drug or drug-food interaction
  • Pregnancy
  • Lactating

Inclusion Criteria

  • Locally advanced, unresectable or metastatic breast cancer
  • Hormone receptor (HR)-positive, HER2-negative disease
  • Activating PIK3CA or AKT1 mutations or PTEN gene alteration as detected by an approved test
  • Progressive disease on or after an endocrine-based regimen

Additional Inclusion Criteria

  • Care is provided by a VA/VA Community Care oncology provider
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1
  • Goals of care and role of Palliative Care consult have been discussed and documented

Reproductive Health & Counseling Requirements

  • Pregnancy must be excluded prior to receiving capivasertib for females who can become pregnant
  • Counseling on potential risks vs benefits of treatment provided for females who can become pregnant and males with partners who can become pregnant
  • Use of effective contraception required during therapy and for 4 months after the last dose for the aforementioned populations

Source Documents

Document 797 Document 812