Overview

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Status:
Active, not recruiting

Trial end date:
2022-06-01

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 efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict™ EPclin Score in women with operable HR+, HER2 negative breast cancer . The Clinical Response Rate, drop in Ki67 index ≤ 2.7% and Breast conserving rate will be compared between two arms.

Phase:

Phase 3

Details

Lead Sponsor:

Kyoto Breast Cancer Research Network

Collaborator:

Pfizer

Treatments:

Hormones
Palbociclib