Overview

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Status:
Active, not recruiting

Trial end date:
2022-02-28

Target enrollment:

Participant gender:

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

Phase:

Phase 3

Details

Lead Sponsor:

Pfizer

Collaborator:

AstraZeneca

Treatments:

Estradiol
Fulvestrant
Goserelin
Hormones
Palbociclib