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Palbociclib and Fulvestrant in HR+, HER2- Metastatic Breast Cancer After Progression on Palbociclib and an AI
NCT02738866Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2016
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of palbociclib and fulvestrant in breast cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoints: Progression-free survival at 6 months and Prevalence of ESR1 and PI3K mutations at 6 months. Started Oct 2016; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Palbociclib and Fulvestrant
Participants receive fulvestrant with palbociclib until disease progression or unacceptable toxicity.
03
Who it enrols
Patients with HR+/HER2- metastatic breast cancer who have progressed on palbociclib and an aromatase inhibitor, with ECOG 0-2, and no prior treatment with fulvestrant or PI3K-mTOR inhibitors.
04
Endpoints
Primary
Progression-free survival
Prevalence of ESR1 and PI3K mutations
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