drugset / Trial / NCT04862663

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

NCT04862663 ↗

Phase 3 Recruiting 895 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2021-05-10
Primary completion
2027-11-01
Completion
2029-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 50 mg —
Subject Abemaciclib Small molecule 100 mg —
Subject Abemaciclib Small molecule 150 mg —
Subject Capivasertib Small molecule 320 mg Oral
Subject Capivasertib Small molecule 400 mg Oral
Subject Fulvestrant Small molecule 500 mg —
Subject Palbociclib Small molecule 100 mg —
Subject Palbociclib Small molecule 125 mg —
Subject Ribociclib Small molecule 200 mg —
Subject Ribociclib Small molecule 400 mg —
Subject Ribociclib Small molecule 600 mg —