Study identifier:D361DC00001
ClinicalTrials.gov identifier:NCT04862663
EudraCT identifier:2020-004637-20
CTIS identifier:N/A
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)
Locally advanced (inoperable) or Metastatic Breast Cancer
Phase 3
No
Capivasertib, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
All
895
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Capivasertib Plus Palbociclib and Fulvestrant Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b) | Drug: Capivasertib Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion Drug: Fulvestrant Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter Drug: Palbociclib Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg. |
Experimental: Capivasertib Plus Ribociclib and Fulvestrant Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b) | Drug: Ribociclib Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion. |
Experimental: Capivasertib Plus Abemaciclib and Fulvestrant Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b) | Drug: Abemaciclib Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle |
Experimental: Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III) | Drug: Capivasertib Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion |
Active Comparator: Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III) | Drug: Fulvestrant Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter |