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Brief Title: 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]
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
Study ID: NCT02297438
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, 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, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Cancer Hospital/Breast cancer department, Tianjin, Tianjin, 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 City, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Block R, Hong Kong, , Hong Kong
Department of Clinical Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, HongKong, , 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
Division of Therapeutic Radiology and Oncology, Department of Radiology, Muang, Chiang MAI, Thailand
Department of Medicine, Faculty of Medicine, Naresuan University, Muang, Phitsanulok, 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
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR