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

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.

Timeline

Start

2019-07-16

Primary completion

2021-12-23

Completion

2021-12-23

Publications

• Ueno T, Chow LWC, Han W, Huang CS, Mann GB, Morita S, Haga H, Fakhrejahani E, Kobayashi T, Bando H, Inoue K, Tokiwa M, Suwa H, Aruga T, Minamiguchi S, Yamada Y, Tanabe Y, Takada M, Yamashita T, Iwata H, Chung CF, Takahara S, Tokunaga E, Imoto S, Lee ES, Sagara Y, Kim JH, DeBoer RH, Kim HA, Lai HW, Hou MF, White M, Umeyama Y, Toi M. Neoadjuvant palbociclib in women with operable, hormone receptor-positive breast cancer. Endocr Relat Cancer. 2025 Sep 11;32(9):e240353. doi: 10.1530/ERC-24-0353. Print 2025 Sep 1.

Drugs

Indications