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]
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, postmenopausal women, estrogen-receptor positive, HER2 negative, locoregionally recurrent, metastatic
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Palbociclib Type: Drug
Name: Letrozole Type: Drug
Name: Placebo Type: Drug
Name: Letrozole Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Locations
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, China
Status: Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Status: Not yet recruiting
Fujian Medical University Union Hospital/Medical Oncology Department
Fuzhou, Fujian, China
Status: Recruiting
Guangdong General Hospital/Department of Breast Surgery
Guangzhou, Guangdong, China
Status: Not yet recruiting
Harbin Medical University Cancer Hospital/Oncology Department
Harbin, Heilongjiang, China
Status: Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, China
Status: Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, China
Status: Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Status: Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Status: Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Status: Not yet recruiting
Jilin Provincial Cancer Hospital
Changchun, Jilin, China
Status: Recruiting
The first hospital of jilin university
Changchun, Jilin, China
Status: Not yet recruiting
Liaoning Province Cancer Hospital
Shenyang, Liaoning, China
Status: Not yet recruiting
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, China
Status: Not yet recruiting
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
307 Hospital of PLA
Beijing, China
Status: Not yet recruiting
Beijing Cancer Hospital
Beijing, China
Status: Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Chinese PLA General Hospital/Oncology
Beijing, China
Status: Not yet recruiting
Peking University Third Hospital/Department of Oncology
Beijing, China
Status: Not yet recruiting
Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA
Chongqing City, China
Status: Not yet recruiting
Clinical Oncology
Hong Kong, Hong Kong
Status: Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong
Status: Recruiting
Start Date
March 2015
Completion Date
October 2017
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page