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

PHASE3CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

July 16, 2019

Primary Completion Date

December 23, 2021

Study Completion Date

December 23, 2021

Conditions
Breast Cancer FemaleHormone Receptor Positive Malignant Neoplasm of Breast
Interventions
DRUG

Palbociclib

Palbociclib will be administered orally once a day for 21 days every 28-day cycle followed by 7 days off treatment

DRUG

Endocrine therapy

Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days plus tamoxifen 20 mg QD in 28-day cycles. Post-menopausal women will receive letrozole 2.5 mg QD in 28-day cycles.

Trial Locations (25)

3168

Monash Health, Clayton

Unknown

Peter MacCallum Cancer Centre, Melbourne

UNIMED Medical Institute, Hong Kong

National Cancer Center, Korea, Gyeonggi-do

Seoul National University Bundang Hospital, Seongnam

Korea Cancer Center Hospital, Seoul

Seoul National University College of Medicine, Seoul

Changhua Christian Hospital, Changhua

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

National Taiwan University Hospital, Taipei

Sun Yat-Sen Cancer Center, Taipei

660-8550

Amagasaki General Medical Center, Amagasaki

305-8576

University of Tsukuba Hospital, Tsukuba

811-1395

Kyushu Cancer Center, Fukuoka

892-0833

Sagara Hospital, Kagoshima

650-0047

Kobe City Medical Center General Hospital, Kobe

606-8507

Kyoto University Hospital, Kyoto

464-8681

Aichi Cancer Center, Nagoya

530-8480

Tazuke Kofukai, Medical Research Institute, Kitano Hospital, Osaka

362-0806

Saitama Cancer Center, Saitama

105-8470

Toranomon Hospital, Tokyo

113-8677

Tokyo Metropolitan Komagome Hospital, Tokyo

135-8550

Cancer Institute Hospital Of JFCR, Tokyo

181-8611

Kyorin University Hospital, Tokyo

241-8515

Kanagawa Cancer Center, Yokohama

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Kyoto Breast Cancer Research Network

OTHER