A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in Women with Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer
Objectives
Primay Objective : To evaluate the efficacy of the pre-operative use of hormonal therapy plus palbociclib vs. hormonal therapy plus placebo as measured by
・PEPI
・EndoPredict™ EPclin Score
Secondary Objective:
Clinical Response Rate,Ki67 change,Pathologicial Response Rate,Breast Conserving Rate,Toxicity Profile
State
Active-Not recruiting
Subjects
Untreated Pre/peri- and Post-Menopausal Women with Operable, ER-positive and HER2-negative Breast Cancer with Ki67 index ≥14% by central assessment
Masakazu Toi(Kyoto University, Professor of Breast Surgery Department)
Louis W.C. Chow (Organisation for Oncology and Translational Research -OOTR)
Takayuki Ueno
(Breast Surgical Oncology Department Director. Cancer Institute Hospital of JFCR)
Target Sample Size
200
Regimen
Palbociclib Treatment
Source of Funding
Pfizer Inc.
Umin ID
-
Other
JMA-IIA00424
NCT03969121
Institutions
Japan, Australia, Korea, Republic of, China, Taiwan, Province of China
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