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 |
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.
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
151
sites
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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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
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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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Blacksburg, Virginia 24060
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Houston, Texas 77030
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1515 Holcombe Blvd
Houston, Texas 77030
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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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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Los Angeles, California 90095
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James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Low Moor, Virginia 24457
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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