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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:September 15, 2008
End Date:December 20, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women

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


Inclusion Criteria:

- 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 Criteria:

- Prior or concomitant treatment for advanced breast cancer.

- Other major cancer in the past 3 years.

- Important cardiovascular events in the past 6 months.
We found this trial at
46
sites
Central Coast Medical Oncology Corporation
220 S Palisade Dr # 204
Santa Maria, California 93454
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Santa Maria, CA
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Central Hematology/Oncology Medical Group, Inc.
Alhambra, California 91801
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Alhambra, CA
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UCLA Hematology/Oncology - Alhambra
Alhambra, California 91801
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Alhambra, CA
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Virginia Cancer Specialists, PC
Arlington, Virginia 22205
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Arlington, VA
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CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California 93309
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Bakersfield, CA
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Illinois Cancer Specialists
Chicago, Illinois 60611
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Chicago, IL
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Resurrection Medical Group
Chicago, Illinois 60057
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Chicago, IL
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North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois 60014
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Crystal Lake, IL
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Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas 75231
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Dallas, TX
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
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Dallas, TX
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Gwinnett Hospital System Inc-d/b/a The Center for Cancer Care
Duluth, Georgia 30096
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Duluth, GA
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Virginia Cancer Specialists, PC
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairfax, VA
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US Oncology Research and Clinical Pharmacy
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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St. Joseph Heritage Healthcare
Fullerton, California 92835
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Fullerton, CA
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Virginia Cancer Specialists, PC
Gainesville, Virginia 20155
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Gainesville, VA
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Regulatory Office: Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89014
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Henderson, NV
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
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Henderson, NV
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North Shore Hematology Oncology
Highland Park, Illinois 60035
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Highland Park, IL
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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Gwinnett Hospital System Inc. -d/b/a-The Center for Cancer Care
Lawrenceville, Georgia 30046
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Lawrenceville, GA
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Virginia Cancer Specialists, PC
Leesburg, Virginia 20176
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Leesburg, VA
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North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois 60048
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Libertyville, IL
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UCLA West Medical Pharmacy (Drug Management Only)
Los Angeles, California 90091
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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Drug Management Only
Los Angeles, California 90095
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Los Angeles, CA
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Regulatory Managment
Los Angeles, California 90095
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Los Angeles, CA
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Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
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Los Angeles, CA
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TORI -US Central Administration (Regulatory Management)
Los Angeles, California 90095
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Los Angeles, CA
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TORI Central Administration (Regulatory Management)
Los Angeles, California 90095
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Los Angeles, CA
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TORI Central Administration (Regulatory Managment Only)
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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Ucla Hematology/Oncology
Los Angeles, California 90095
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Los Angeles, CA
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Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California 90095
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Los Angeles, CA
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TORI -US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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Central Hematology Oncology Medical Group Inc.
Pasadena, California 91107
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Pasadena, CA
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Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California 90277
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Redondo Beach, CA
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Sansum- Santa Barbara medical foundation Clinic
Santa Barbara, California 93101
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Santa Barbara, CA
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Santa Monica/UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California 90404
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Santa Monica, CA
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UCLA Hematology-Oncology Santa Monica
Santa Monica, California 90404
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Santa Monica, CA
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North Shore Hematology Oncology
Skokie, Illinois 60077
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Skokie, IL
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Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care
Snellville, Georgia 30078
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Snellville, GA
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UCLA Hematology/Oncology - Santa Clarita
Valencia, California 91355
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Valencia, CA
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BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia
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Vancouver,
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Virginia Cancer Specialists, PC
Woodbridge, Virginia 22191
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Woodbridge, VA
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