Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
1 other identifier
expanded_access
N/A
2 countries
55
Brief Summary
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 20, 2014
CompletedDecember 21, 2018
December 1, 2018
May 16, 2014
December 20, 2018
Conditions
Keywords
Interventions
Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
Eligibility Criteria
You may qualify if:
- Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
- ER-positive and/or PR-positive tumor based on local laboratory results
- HER2-negative tumor based on local laboratory results
- Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)
You may not qualify if:
- Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (55)
CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
Bakersfield, California, 93309, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
Duluth, Georgia, 30096, United States
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
Lawrenceville, Georgia, 30046, United States
Presence Saint Joseph Hospital
Chicago, Illinois, 60657, United States
North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois, 60014, United States
North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois, 60048, United States
Presence Medical Group Hematology Oncology
Northbrook, Illinois, 60062, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Presence Infusion Care - Skokie
Skokie, Illinois, 60077, United States
Metairie Oncologist, LLC
Metairie, Louisiana, 70006, United States
SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
Baltimore, Maryland, 21287, United States
SKCCC at Johns Hopkins, Green Spring Station
Lutherville, Maryland, 21093, United States
The West Clinic, P.C.
Corinth, Mississippi, 38834, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
Mississippi Baptist Health Systems
Jackson, Mississippi, 39202, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39216, United States
The West Clinic, P.C. d/b/a West Cancer Center
Southaven, Mississippi, 38671, United States
ProHealthCARE Associates, LLP
Lake Success, New York, 11042, United States
Northwest Cancer Specialists dba Compass Oncology
Portland, Oregon, 97213, United States
Northwest Cancer Specialists dba Compass Oncology
Portland, Oregon, 97225, United States
UPMC Cancer Center Beaver
Beaver, Pennsylvania, 15009, United States
UPMC Cancer Center Arnold Palmer at Mountainview
Greensburg, Pennsylvania, 15601, United States
UPMC Cancer Center Greenville
Greenville, Pennsylvania, 16125, United States
UPMC Cancer Center Monroeville
Monroeville, Pennsylvania, 15146, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
UPMC Cancer Center St. Margarets
Pittsburgh, Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
Pittsburgh, Pennsylvania, 15232, United States
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
UPMC Cancer Center Passavant (HOA)
Pittsburgh, Pennsylvania, 15237, United States
UPMC Cancer Center Passavant (OHA)
Pittsburgh, Pennsylvania, 15237, United States
UPMC Cancer Center Northwest
Seneca, Pennsylvania, 16346, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, 38138, United States
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, 38104, United States
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, 38120, United States
Texas Oncology -Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
Fairfax, Virginia, 22031, United States
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
Reston, Virginia, 20190, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Northwest Cancer Specialists dba Compass Oncology
Vancouver, Washington, 98683, United States
Northwest Cancer Specialists dba Compass Oncology
Vancouver, Washington, 98684, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Holy Cross Centre
Calgary, Alberta, T2S 3C3, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
SunnyBrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec - Hospital du Saint-Sacrement
Québec, Quebec, G1S 4L8, Canada
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer