NCT02491983

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Detailed description

Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib
DRUG	Fulvestrant
DRUG	Letrozole

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2015-07-08
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

48 sites across 7 countries: Czechia, France, Germany, Italy, Russia, Spain, United Kingdom