Phase Ib/III Study of Capivasertib + CDK4/6 Inhibitors + Fulvestrant as Treatment for Advanced/Metastatic HR+/HER2-Breast Cancer (CAPItello-292)

Brief summary (registry, in English)

Phase Ib: To assess the safety and tolerability of capivasertib plus CDK4/6i (palbociclib, ribociclib or abemaciclib) and fulvestrant when dosed concomitantly in participants with advanced breast cancer. To confirm the recommended Phase III dose (RP3D) and/or maximum tolerated dose (MTD) of the triplets. Phase III: To demonstrate the superiority of the capivasertib arm relative to control arm by assessment of PFS in participants with HR+/HER2- locally advanced or metastatic breast cancer (overall population), and/or, in participants with gene alterations detected in PIK3CA, AKT1 and/or PTEN (altered population), and/or, in participants without gene alterations (confirmed non-altered population).

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 214
• 65 sites in 8 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (65)

Sites in registry order. Pick your city on the disease page to sort them by distance.