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
2 other identifiers
interventional
340
5 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2015
Longer than P75 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedStudy Start
First participant enrolled
March 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedResults Posted
Study results publicly available
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2025
CompletedMay 14, 2026
April 1, 2026
5.4 years
November 19, 2014
July 26, 2021
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Based on Investigator's Assessment: Up to Primary Completion Date
PFS was based on Kaplan-Meier estimates. PFS was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. In this outcome measure, PFS was based on investigator's assessment.
Randomization up to 65 months
Secondary Outcomes (23)
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR): Up to Primary Completion Date
Randomization up to 65 months
Percentage of Participants With Objective Response (OR) Based on Investigator Assessment: Up to Primary Completion Date
Randomization up to 65 months
Percentage of Participants With Objective Response (OR) Based on Investigator Assessment (Participants With Measurable Disease at Baseline): Up to Primary Completion Date
Randomization up to 65 months
Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR): Up to Primary Completion Date
Randomization up to 65 months
Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR) (Participants With Measurable Disease at Baseline): Up to Primary Completion Date
Randomization up to 65 months
- +18 more secondary outcomes
Other Outcomes (5)
Overall Survival: Up to Secondary Completion Date
Randomization up to 65 months
Number of Participants With Treatment-Emergent Adverse Events (All Causalities): Up to Secondary Completion Date
Up to 28 days after last dose of study drug or start of new treatment (data collection maximum up to approximately 119 months after randomization)
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related): Up to Secondary Completion Date
Up to 28 days after last dose of study drug or start of new treatment (data collection maximum up to approximately 119 months after randomization)
- +2 more other outcomes
Study Arms (2)
Palbociclib + Letrozole
EXPERIMENTALPalbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously)
Placebo + Letrozole
ACTIVE COMPARATORPlacebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Interventions
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Confirmed diagnosis of HER2 positive disease
- Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
- Known uncontrolled or symptomatic CNS metastases
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (54)
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Fujian Medical University Union Hospital/Medical Oncology Department
Fuzhou, Fujian, 350001, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Zhongshan Ophthalmic Center,Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510120, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital/Oncology Department
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Provincial Tumor Hospital/Breast Internal Medicine Department
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130103, China
The First Hospital of China Medical University/Oncology Department
Shenyang, Liaoning, 110001, China
Liaoning Province Cancer Hospital
Shenyang, Liaoning, 110042, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital/Breast cancer department
Tianjin, Tianjin Municipality, 300060, China
The Tumor Hospital of Yunnan Province
Kunming, Yunnan, 650118, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
307 Hospital of PLA
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
Peking University Third Hospital/Department of Oncology
Beijing, 100191, China
Chinese PLA General Hospital/Oncology
Beijing, 100853, China
Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA
Chongqing, 400037, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Department of Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Raffles Cancer Centre
Singapore, 188770, Singapore
Parkway Cancer Centre
Singapore, 258500, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Tan Tock Seng Hospital
Singapore, 308442, Singapore
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital / Internal Medicine
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Medical University Hospital/ Department of Surgery
Taipei, 110, Taiwan
Taipei Veterans General Hospital/Surgery Department
Taipei, 11217, Taiwan
Koo Foundation, Sun Yat-Sen Cancer Center
Taipei, 11259, Taiwan
Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University )
Taipei, 116, Taiwan
King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, 10330, Thailand
Chula Clinical Research Center (Chula CRC)
Patumwan, Bangkok, 10330, Thailand
Department of Medicine, Faculty of Medicine, Naresuan University
Muang, Changwat Phitsanulok, 65000, Thailand
Division of Therapeutic Radiology and Oncology, Department of Radiology
Muang, Chiang Mai, 50200, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Ratchathevi, 10400, Thailand
Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Bangkok, 10400, Thailand
Division of Medical Oncology, Department of Medicine,
Bangkok, 10700, Thailand
Related Publications (2)
Xu B, Hu X, Li W, Sun T, Shen K, Huang C, Sriuranpong V, Ngan RK, Chia YH, Reisman A, Zhao H, Shen J, Broughton E. Patient-reported quality of life in Asian patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the PALOMA-4 trial. Chin Med J (Engl). 2024 Dec 19. doi: 10.1097/CM9.0000000000003122. Online ahead of print.
PMID: 39694573DERIVEDXu B, Hu X, Li W, Sun T, Shen K, Wang S, Cheng Y, Zhang Q, Cui S, Tong Z, Geng C, Song E, Huang CS, Sriuranpong V, Ngan RKC, Chia YH, Wang X, Zhao H. Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4. Eur J Cancer. 2022 Nov;175:236-245. doi: 10.1016/j.ejca.2022.08.012. Epub 2022 Sep 22.
PMID: 36155117DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2014
First Posted
November 21, 2014
Study Start
March 23, 2015
Primary Completion
August 31, 2020
Study Completion
February 24, 2025
Last Updated
May 14, 2026
Results First Posted
November 18, 2021
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.