A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:February 22, 2013
End Date:June 30, 2020

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A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

The study is designed to compare the clinical benefit following treatment with letrozole in
combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal
women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti
cancer therapies for their advanced/metastatic disease.


Inclusion Criteria:

- Adult 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] 0-2

- 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 (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from
completion of treatment.

- Prior treatment with any CDK 4/6 inhibitor.
We found this trial at
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1150 N 35th Ave # 330
Hollywood, Florida 33021
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24 Sturtevant St
Orlando, Florida 32806
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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220 S Palisade Dr # 204
Santa Maria, California 93454
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, Georgia 30303
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Atlanta, Georgia 30322
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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BellFlower, California 90706
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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Beverly Hills, California 90211
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Brewster, New York 10509
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Coeur d'Alene, Idaho 83814
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Corinth, Mississippi 38834
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Darlinghurst, New South Wales 2010
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Deerfield Beach, Florida 33442
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Dickson, Tennessee 37055
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Evanston, Illinois 60202
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Fort Lee, New Jersey 07024
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Franklin, Tennessee 37067
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Fullerton, California 92835
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Gallatin, Tennessee 37066
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Germantown, Tennessee 38138
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Grand Island, Nebraska 68803
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Grand Junction, Colorado 81501
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Hastings, Nebraska 68901
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Hermitage, Tennessee 37076
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Hollywood, Florida 33021
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Irvine, California 92604
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Jacksonville, Florida 32256
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Laguna Hills, California 92653
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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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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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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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3730 South Eastern Avenue
Las Vegas, Nevada 89119
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Lebanon, Tennessee 37087
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90017
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Los Angeles, California 90045
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Los Angeles, California 90027
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Marietta, Georgia 30060
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Mount Kisco, New York 10549
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Mount Kisco, New York 10549
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