Capivasertib + Palbociclib + Fulvestrant for HR+/HER2- Advanced Breast Cancer (CAPItello-292).
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Locally Advanced (Inoperable) or Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase Ib: Open, Parallel groups allowed, recruiting approx. 72 participants. Phase III: Randomised, double blind, recruiting approx. 628 participants.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with palbociclib and fulvestrant in participants with endocrine-resistant locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing re...
This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with palbociclib and fulvestrant in participants with endocrine-resistant locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of palbociclib + fulvestrant are established, the dose and schedule for the triplet combination (capivasertib + palbociclib + fulvestrant) needs to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will confirm the recommended Phase III doses (RP3D) and schedule of administration of capivasertib and palbociclib for the triplet combination including fulvestrant which will then be used in the Phase III part of this study.
Tracking Information
- NCT #
- NCT04862663
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon