Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
This study is testing a new combination of medicines for people with locally advanced (inoperable) or metastatic (spread to other parts of the body) breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-). It combines capivasertib with fulvestrant and a CDK4/6 inhibitor (either palbociclib or ribociclib). Researchers want to find the best doses for this three-drug combination and see how well it works and if it's safe. Success will be measured by looking at side effects and how many people experience them. You may be able to join if you are an adult (18-99 years old) male or female with this type of breast cancer. The study is currently unclear about its recruitment status.
- Study design
- This is an open-label (meaning you and your doctors will know which treatment you are receiving), randomized (meaning you will be assigned to a treatment group by chance) Phase Ib/III study planning to enroll 895 participants.
- What's involved
- You would take capivasertib, fulvestrant, and either palbociclib or ribociclib according to specific schedules over 28-day cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for treatment-related adverse events (side effects) and serious adverse events for up to approximately 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
At a glance
Conditions
Where it's being run
225 sites across 47 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.Within the first 28 day cycle.
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.
- Phase Ib: 2. The number of participants with treatment-related adverse events.From baseline up to approximately 36 months.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.
- Phase Ib: 3. The number of participants with treatment-related serious adverse events.From baseline up to approximately 36 months.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.
- Phase III: 1. Progression Free Survival (PFS).Up to approximately 47 months.
Progression Free Survival (PFS) is defined as time from randomization until progression per RECIST v1.1. as assessed by BICR or death due to any cause in the overall population, the altered population, and the confirmed non-altered population. RECIST related endpoints such as PFS, ORR, DoR, CBR will be collected.