Status:
COMPLETED
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
Eligibility Criteria
Inclusion
- Inoperable estrogen receptor positive and HER2 negative breast cancer.
- Postmenopausal status.
- Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
- Acceptable bone marrow, liver and kidney function.
Exclusion
- Prior or concomitant treatment for advanced breast cancer.
- Other major cancer in the past 3 years.
- Important cardiovascular events in the past 6 months.
Key Trial Info
Start Date :
September 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00721409
Start Date
September 15 2008
End Date
December 20 2017
Last Update
November 4 2019
Active Locations (104)
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1
Central Hematology Oncology Medical group Inc.
Alhambra, California, United States, 91801
2
UCLA Hematology/Oncology - Alhambra
Alhambra, California, United States, 91801
3
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
4
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835