Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00721409

Run by

Pfizer

People needed

177

Starts

2008-09-15

Expected to finish

2017-12-20

Last updated by the study team

2019-11-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior or concomitant treatment for advanced breast cancer.
• Other major cancer in the past 3 years.
• Important cardiovascular events in the past 6 months.

Where it is running

• UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States
• CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• UCLA West Medical Pharmacy (Drug Management Only) — Los Angeles, California, United States
• UCLA West Medical Pharmacy — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA West Medical Pharmacy — Los Angeles, California, United States
• Drug Management Only: UCLA West Medical Pharmacy — Los Angeles, California, United States
• Drug Management Only — Los Angeles, California, United States
• Regulatory Managment — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• TORI -US Central Administration (Regulatory Management) — Los Angeles, California, United States
• TORI -US Central Administration — Los Angeles, California, United States
• TORI Central Administration (Regulatory Management) — Los Angeles, California, United States
• TORI Central Administration (Regulatory Managment Only) — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UCLA, Hematology/Oncology — Los Angeles, California, United States
• Westwood Bowyer Clinic, Peter Morton Medical Building — Los Angeles, California, United States
• Central Hematology Oncology Medical Group, Inc — Pasadena, California, United States
• Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates — Redondo Beach, California, United States
• Sansum Santa Barbara Medical Foundation Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Santa Monica-UCLA Medical Center and Orthopaedic Hospital — Santa Monica, California, United States
• Central Hematology Oncology Medical group Inc. — Alhambra, California, United States

Full record on ClinicalTrials.gov

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