Overview

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Status:
Active, not recruiting

Trial end date:
2026-02-28

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

Phase:

Phase 3

Details

Lead Sponsor:

Alliance Foundation Trials, LLC.

Collaborators:

Alliance Foundation Trials Biorepository - Washington State University
Alliance Foundation Trials Central Imaging Core Lab - Ohio State University
Breast Cancer Trials, Australia and New Zealand
Fondazione Michelangelo
German Breast Group
German Breast Group (GBG)
INC Research
Mastering Breast Cancer Initiative, LLC
Mayo Clinic Statistics and Data Center
Pfizer
PrECOG, LLC.
SOLTI Breast Cancer Research Group
Syneos Health
The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG)
UNICANCER

Treatments:

Anastrozole
Exemestane
Fulvestrant
Letrozole
Palbociclib
Pertuzumab
Trastuzumab