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]

PHASE3CompletedINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

March 23, 2015

Primary Completion Date

August 31, 2020

Study Completion Date

February 24, 2025

Conditions
Breast Neoplasms
Interventions
DRUG

Palbociclib

Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

DRUG

Placebo

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

Trial Locations (54)

100

National Taiwan University Hospital, Taipei

110

Taipei Medical University Hospital/ Department of Surgery, Taipei

116

Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University ), Taipei

704

National Cheng Kung University Hospital / Internal Medicine, Tainan City

10330

King Chulalongkorn Memorial Hospital, Pathumwan

Chula Clinical Research Center (Chula CRC), Patumwan

10400

Ramathibodi Hospital, Mahidol University, Bangkok

Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok

10449

Mackay Memorial Hospital, Taipei

10700

Division of Medical Oncology, Department of Medicine,, Bangkok

11217

Taipei Veterans General Hospital/Surgery Department, Taipei

11259

Koo Foundation, Sun Yat-Sen Cancer Center, Taipei

40447

China Medical University Hospital, Taichung

50200

Division of Therapeutic Radiology and Oncology, Department of Radiology, Muang

65000

Department of Medicine, Faculty of Medicine, Naresuan University, Muang

100021

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

100071

307 Hospital of PLA, Beijing

100142

Beijing Cancer Hospital, Beijing

100191

Peking University Third Hospital/Department of Oncology, Beijing

100853

Chinese PLA General Hospital/Oncology, Beijing

110001

The First Hospital of China Medical University/Oncology Department, Shenyang

110042

Liaoning Province Cancer Hospital, Shenyang

130021

The First Hospital of Jilin University, Changchun

130103

Jilin Provincial Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital/Oncology Department, Harbin

188770

Raffles Cancer Centre, Singapore

200025

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

210029

Jiangsu Province Hospital, Nanjing

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

233004

The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department, Bengbu

258500

Parkway Cancer Centre, Singapore

300060

Tianjin Cancer Hospital/Breast cancer department, Tianjin

308433

Tan Tock Seng Hospital, Singapore

308442

Tan Tock Seng Hospital, Singapore

310003

The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

310016

Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

350001

Fujian Medical University Union Hospital/Medical Oncology Department, Fuzhou

400037

Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA, Chongqing

410011

The Second Xiangya Hospital of Central South University, Changsha

410013

Hunan Provincial Tumor Hospital/Breast Internal Medicine Department, Changsha

430079

Hubei Cancer Hospital, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510060

Sun Yat-Sen University Cancer Center, Guangzhou

Zhongshan Ophthalmic Center,Sun Yat-Sen University, Guangzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

510120

Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

650118

The Tumor Hospital of Yunnan Province, Kunming

050011

Fourth Hospital of Hebei Medical University, Shijiazhuang

Unknown

Department of Clinical Oncology, Hong Kong

Queen Mary Hospital, Hong Kong

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02297438 - 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] | Biotech Hunter | Biotech Hunter