Clinical Trial

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

MOA: Capivasertib is an oral pan-AKT inhibitor

Key Eligibility Criteria:

• Men and women with adv/metastatic HR+/HER2- breast cancer
• Pre-/perimenopausal women, men must receive concurrent tx w/ LHRH
  agonist
• Pt must have progressed on or w/in 12 months of (neo)adjuvant ET
  (single agent or in combo)
• Maximum 1L chemotherapy in metastatic setting
• Measurable disease per RECIST v1.1 or lytic/mixed bone lesion
• Mandatory FFPE tumor sample for central testing
• Mandatory blood samples at screening for central testing
• Previous tx w/ AKT, PI3K, mTOR inhibitors excluded
• Endocrine-based therapy or CDK4/6i in metastatic setting excluded