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 |
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).
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
6435 Chippewa Street
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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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13001 East 17th Place
Aurora, Colorado 80045
Aurora, Colorado 80045
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1635 Aurora Court
Aurora, Colorado 80045
Aurora, Colorado 80045
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Deerfield Beach, Florida 33442
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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Fort Lauderdale, Florida 33308
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3855 Health Sciences Dr,
La Jolla, California 92093
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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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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
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
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
Las Vegas, Nevada 89119
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1441 Eastlake Ave
Los Angeles, California 90033
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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Lutherville, Maryland 21093
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