Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:September 26, 2013
End Date:January 2, 2020

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MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the
primary objective of demonstrating the superiority of palbociclib in combination with
fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2
negative metastatic breast cancer whose disease has progressed after prior endocrine therapy.
The safety between the two treatment arms will also be compared. During study treatment, pre-
and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex®
or generic).


Inclusion Criteria:

- Women 18 years or older with metastatic or locally advanced disease, not amenable to
curative therapy

- Confirmed diagnosis of HR+/HER2- breast cancer

- Any menopausal status

- Progressed within 12 months from prior adjuvant or progressed within 1 month from
prior advanced/metastatic endocrine breast cancer therapy

- On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to
switch to goserelin (Zoladex ®) at time of randomization.

- Measurable disease defined by RECIST version 1.1, or bone-only disease

- Eastern Cooperative Oncology Group (ECOG) PS 0-1

- Adequate organ and marrow function, resolution of all toxic effects of prior therapy
or surgical procedures

- Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

- Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that
inhibits the PI3K-mTOR pathway

- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known
uncontrolled or symptomatic CNS metastases

- Major surgery or any anti-cancer therapy within 2 weeks of randomization

- Prior stem cell or bone marrow transplantation

- Use of potent CYP3A4 inhibitors or inducers
We found this trial at
162
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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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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220 S Palisade Dr # 204
Santa Maria, California 93454
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Arlington, Virginia 22205
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Asheville, North Carolina 28801
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Asheville, North Carolina 28806
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Atlanta, Georgia 30318
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12605 East 16th Avenue
Aurora, Colorado 80045
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13001 East 17th Place
Aurora, Colorado 80045
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Avondale, Arizona 85323
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Bankstown, New South Wales 2200
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Birmingham, Alabama 35249
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185 New York 312
Brewster, New York 10509
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Charlottesville, Virginia 22903
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1215 Lee Street
Charlottesville, Virginia 22903
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Charlottesville, Virginia
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655 Maryville Centre Drive
Chesterfield, Missouri 63017
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Culver City, California 90232
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Daphne, Alabama 36526
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Duarte, California 91010
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Edina, Minnesota 55435
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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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8505 Arlington Boulevard
Fairfax, Virginia 22031
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Fairfax, Virginia 22031
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Fayetteville, Georgia 30214
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1329 North Beaver Street
Flagstaff, Arizona 86001
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Germantown, Tennessee 38138
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Glendale, Arizona 85306
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Goodyear, Arizona 85338
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, California 92037
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Lake Success, New York 11042
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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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Leesburg, Virginia 20176
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Los Angeles, California 90033
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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757 Westwood Plaza
Los Angeles, California 90095
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757 Westwood Plaza
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Marietta, Georgia 30060
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Mequon, Wisconsin 53097
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