Status:
COMPLETED
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]
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT02297438
Start Date
March 23 2015
End Date
February 24 2025
Last Update
October 27 2025
Active Locations (54)
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1
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, China, 233004
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
3
Fujian Medical University Union Hospital/Medical Oncology Department
Fuzhou, Fujian, China, 350001
4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060