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A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Sponsor: Pfizer
Summary
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Official title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF PREVIOUSLY UNTREATED ASIAN POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2015-03-23
Completion Date
2025-02-24
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Palbociclib
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Locations (54)
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Fujian Medical University Union Hospital/Medical Oncology Department
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center,Sun Yat-Sen University
Guangzhou, Guangdong, China
Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital/Oncology Department
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Provincial Tumor Hospital/Breast Internal Medicine Department
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Jilin Provincial Cancer Hospital
Changchun, Jilin, China
The First Hospital of China Medical University/Oncology Department
Shenyang, Liaoning, China
Liaoning Province Cancer Hospital
Shenyang, Liaoning, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital/Breast cancer department
Tianjin, Tianjin Municipality, China
The Tumor Hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
307 Hospital of PLA
Beijing, China
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital/Department of Oncology
Beijing, China
Chinese PLA General Hospital/Oncology
Beijing, China
Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA
Chongqing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Department of Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Raffles Cancer Centre
Singapore, Singapore
Parkway Cancer Centre
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital / Internal Medicine
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Taipei Medical University Hospital/ Department of Surgery
Taipei, Taiwan
Taipei Veterans General Hospital/Surgery Department
Taipei, Taiwan
Koo Foundation, Sun Yat-Sen Cancer Center
Taipei, Taiwan
Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University )
Taipei, Taiwan
King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand
Chula Clinical Research Center (Chula CRC)
Patumwan, Bangkok, Thailand
Department of Medicine, Faculty of Medicine, Naresuan University
Muang, Changwat Phitsanulok, Thailand
Division of Therapeutic Radiology and Oncology, Department of Radiology
Muang, Chiang Mai, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Ratchathevi, Thailand
Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Bangkok, Thailand
Division of Medical Oncology, Department of Medicine,
Bangkok, Thailand