Brief Summary
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advancedat a late stage, far along, Unresectable or Metastatic Breast Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (CAPItello-292).
Intervention / Treatment
- Drug: Capivasertib
- Drug: Fulvestrant
- Drug: Palbociclib
- Drug: Ribociclib
- Drug: Abemaciclib
Inclusion Criteria
Key inclusion criteria for both phases:
- Adult females (pre-/peri-/ and post-menopausal), and adult males.
- Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumoura tissue mass that forms from groups of unhealthy cells sample (primary or metastatic) per the American Society of Clinical Oncologythe study, diagnosis and treatment of cancer 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 dosethe amount of medication taken levels required.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells functions.
- Consent to provide a mandatory FFPE tumour sample.
Key inclusion criteria only for phase III:
- Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrenceto occur or happen again or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.
- Provision of mandatory bloodthe red bodily fluid that transports oxygen and other nutrients around the body samples at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
- Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imagingtests that create detailed images of areas inside the body (MRI).