Phase II Trial of Palbociclib With Fulvestrant in Individuals With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Who Have Progressed on Treatment With Palbociclib and an Aromatase Inhibitor

NCT02738866 Phase 2 ACTIVE_NOT_RECRUITING

This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase inhibitor.

Details

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	60
Start date	2016-10-25
Completion	2026-06

Conditions

• Metastatic Breast Cancer

Interventions

• Palbociclib
• Fulvestrant

Primary outcomes

• Progression-free survival — 6 months
  To estimate progression-free survival (PFS) of palbociclib and fulvestrant in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI
• Prevalence of ESR1 and PI3K mutations — 6 months
  To determine the prevalence of ESR1 and PI3K mutations in tissue and in ptDNA in women and men with ER/PR-positive, HER2-negative MBC who progressed on a palbociclib and an AI

Countries

United States