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NCT02297438CompletedPhase 3

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]

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
340 (actual)
First submitted
19 Nov 2014
Start date
23 Mar 2015
Primary completion date
31 Aug 2020
Lead sponsor
Pfizer
NCT number
NCT02297438

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 340
  • From 23 Mar 2015 to the primary completion date, 31 Aug 2020
  • 53 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
  • Prior treatment with any CDK 4/6 inhibitor

Other illness

  • Confirmed diagnosis of HER2 positive disease

Other

  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases

Who the study is looking for

  • Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
  • Eastern Cooperative Oncology Group \[ECOG\] 0-1
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peking University Third Hospital/Department of Oncology
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Chinese PLA General Hospital/Oncology
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BeijingChinaUnknown status
307 Hospital of PLA
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BeijingChinaUnknown status
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Coordinator of this site? Confirm its status
BengbuChinaUnknown status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Jilin Provincial Cancer Hospital
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
The Second Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Hunan Provincial Tumor Hospital/Breast Internal Medicine Department
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
West China Hospital of Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Fujian Medical University Union Hospital/Medical Oncology Department
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Zhongshan Ophthalmic Center,Sun Yat-Sen University
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GuangzhouChinaUnknown status
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The First Affiliated Hospital of College of Medicine,Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital/Oncology Department
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HarbinChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
The Tumor Hospital of Yunnan Province
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KunmingChinaUnknown status
Jiangsu Cancer Hospital
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NanjingChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Liaoning Province Cancer Hospital
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ShenyangChinaUnknown status
The First Hospital of China Medical University/Oncology Department
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ShenyangChinaUnknown status
Fourth Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaUnknown status
Tianjin Cancer Hospital/Breast cancer department
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Queen Mary Hospital
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Hong KongHong KongUnknown status
Department of Clinical Oncology
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Hong KongHong KongUnknown status
Raffles Cancer Centre
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SingaporeSingaporeUnknown status
Tan Tock Seng Hospital
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SingaporeSingaporeUnknown status
Parkway Cancer Centre
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SingaporeSingaporeUnknown status
Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Ramathibodi Hospital, Mahidol University
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Division of Medical Oncology, Department of Medicine,
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Division of Therapeutic Radiology and Oncology, Department of Radiology
Coordinator of this site? Confirm its status
MuangThailandUnknown status
Department of Medicine, Faculty of Medicine, Naresuan University
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MuangThailandUnknown status
King Chulalongkorn Memorial Hospital
Coordinator of this site? Confirm its status
PathumwanThailandUnknown status
Chula Clinical Research Center (Chula CRC)
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PatumwanThailandUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital / Internal Medicine
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TainanTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University Hospital/ Department of Surgery
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TaipeiTaiwanUnknown status
Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University )
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Koo Foundation Sun Yat-Sen Cancer Center
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital/Surgery Department
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.