ClinicaliQ Trial Snapshot
- Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) — Recruiting • Phase III • Oncology • NCT04862663.
- What is being tested: Capivasertib (AKT inhibitor) combined with CDK4/6 inhibitors and fulvestrant compared to CDK4/6 inhibitors and fulvestrant alone in advanced/metastatic HR+/HER2- breast cancer, with the aim of improving progression-free and overall survival.
- Patient eligibility overview: Women with locally advanced, unresectable, or metastatic hormone receptor-positive, HER2-negative breast cancer; includes both treatment-Phase IIIïve and prior endocrine therapy-treated patients, with adequate organ function and performance status.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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)
Eligibility Snapshot
- Key inclusion criteria for both phases:
- Adult females (pre-/peri-/ and post-menopausal), and adult males. 2. Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 3. Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required. 4. Adequate organ and bone marrow functions. 5. Consent to provide a mandatory FFPE tumour sample. Key inclusion criteria only for phase III: 1. Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen. 2. Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status. 3. Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.