CAPItello-292
Research type
Research Study
Full title
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 andHuman Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
IRAS ID
1008193
Contact name
Assim Khan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-004637-20
Research summary
This study is being done to learn how well the investigational drug, called Capivasertib, combined with standard treatment (CDK4/6 inhibitors (CDK4/6i) and fulvestrant) works and how safe it is compared with the standard treatment alone, in people with advanced or metastatic HR+/HER2- breast cancer. This study has two parts called phases. In phase 1b, patients will receive Capivasertib + CDK4/6i palbociclib, ribociclib, or abemaciclib) + fulvestrant. These drugs will be given at different doses to understand what the safe and tolerable doses are; then these safe and tolerable doses will be given in phase 3. In phase 3, 1 group will receive Capivasertib + standard treatment, while the other group will receive standard treatment only. Researchers think that Capivasertib + standard treatment could work better for treating aggressive forms of advanced or metastatic HR+/HER2- breast cancer than standard treatment alone; the goal of Phase 3 is to better understand this. Capivasertib is an anti-cancer drug designed to stop on of the proteins in the body that helps tumors grow and spread. In phase 3, in each cycle: Capivasertib is taken orally for 4 days and stopped for 3 days, CDK4/6i is taken orally for 21 days, and stopped for 7 days and Fulvestrant injection is given once (and one extra dose in the first cycle, 2 weeks after the first dose). Patients who meet the screening criteria will be randomly assigned a study treatment and have a 50% chance of being given the investigational treatment. There will be approximately 222 participants in phase Ib and approximately 628 in phase 3, in about 23 countries all over the world. Participants will have to attend regular clinic visits for treatment, physical exams, blood, urine and other safety tests, along with imaging scans. This study is planned to last for about 8 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0185
Date of REC Opinion
18 Oct 2023
REC opinion
Further Information Favourable Opinion