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
- Diseases
- Metastatic breast cancer
- 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
Sites (53)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital/Department of Oncology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital/Oncology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| 307 Hospital of PLA Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Jilin Provincial Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hunan Provincial Tumor Hospital/Breast Internal Medicine Department Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital/Medical Oncology Department Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhongshan Ophthalmic Center,Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of College of Medicine,Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital/Oncology Department Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Tumor Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Province Cancer Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Hospital of China Medical University/Oncology Department Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Tianjin Cancer Hospital/Breast cancer department Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Department of Clinical Oncology Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Raffles Cancer Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Tan Tock Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Parkway Cancer Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Ramathibodi Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Division of Medical Oncology, Department of Medicine, Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Division of Therapeutic Radiology and Oncology, Department of Radiology Coordinator of this site? Confirm its status | Muang | Thailand | Unknown status |
| Department of Medicine, Faculty of Medicine, Naresuan University Coordinator of this site? Confirm its status | Muang | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Pathumwan | Thailand | Unknown status |
| Chula Clinical Research Center (Chula CRC) Coordinator of this site? Confirm its status | Patumwan | Thailand | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital / Internal Medicine Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Hospital/ Department of Surgery Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University ) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Koo Foundation Sun Yat-Sen Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital/Surgery Department Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.