PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Step 1: 800 patients screened for circulating blood ESR1 mutation detection at regular intervals will be treated with palbociclib 125 mg once daily for 21 days followed by 7 days off (28-day cycle) + AI (letrozole, anastrozole or exemestane) administered once daily in a continuous scheme (EoT if RECIST tumor progression or ESR1 mutation detection) Step 2: 160 Patients with a rising circulating ESR1 mutation and without tumor progression will be randomized (1:1): ARM A: no change in therapy. EoT if tumor progression or possibility of a cross-over (step 3) ARM B: palbociclib 125 mg + fulvestrant 500 mg administered intramuscularly on D1,15 and 29 and once monthly thereafter. EoT if RECIST tumor progression Step 3 (cross over): 80 patients who have been randomized in arm A will be offered to be treated by fulvestrant + palbociclib, after having progressed under AI + palbociclib. The EoT will occur at the tumor progression under fulvestrant + palbociclib Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03079011
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: François-Clément BIDARD, MD PhD Institut Curie
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