Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (NCT04862663) | Clinical Trial Compass
RecruitingPhase 3
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
United States895 participantsStarted 2021-05-10
Plain-language summary
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)
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Adult females (pre-/peri-/ and post-menopausal), and adult males.
✓. 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.
✓. 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.
✓. Adequate organ and bone marrow functions.
✓. Consent to provide a mandatory FFPE tumour sample.
✓. 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.
✓. Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.
✓. Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.
Exclusion criteria
✕. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
What they're measuring
1
Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.
Timeframe: Within the first 28 day cycle.
2
Phase Ib: 2. The number of participants with treatment-related adverse events.
Timeframe: From baseline up to approximately 36 months.
3
Phase Ib: 3. The number of participants with treatment-related serious adverse events.
Timeframe: From baseline up to approximately 36 months.
✕. Radiotherapy within 2 weeks prior to study treatment initiation.
✕. Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.
✕. Persistent toxicities (CTCAE Grade \>1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician.
✕. Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation.
✕. Any of the following cardiac criteria at screening:
✕. uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation
✕. Any of these clinically significant abnormalities of glucose metabolism at screening: