Clinical trial NCT02142868: 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
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Advanced Breast Cancer (Female)
Keywords: Expanded Access
Advanced Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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).

Detailed description: This study is currently available in Canada only.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
state: California
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute at MedStar Washington Hospital Center
state: District of Columbia
city: Duluth
country: United States
facility: Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
state: Georgia
city: Chicago
country: United States
facility: Presence Saint Joseph Hospital
state: Illinois
city: Crystal Lake
country: United States
facility: North Shore Oncology-Hematology Associates, Ltd.
state: Illinois
city: Libertyville
country: United States
facility: North Shore Oncology-Hematology Associates, Ltd.
state: Illinois
city: Northbrook
country: United States
facility: Presence Medical Group Hematology Oncology
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Skokie
country: United States
facility: Presence Infusion Care - Skokie
state: Illinois
city: Metairie
country: United States
facility: Metairie Oncologist, LLC
state: Louisiana
city: Baltimore
country: United States
facility: SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
state: Maryland
city: Lutherville
country: United States
facility: SKCCC at Johns Hopkins, Green Spring Station
state: Maryland
city: Corinth
country: United States
facility: The West Clinic, P.C.
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Jackson
country: United States
facility: Mississippi Baptist Health Systems
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Mississippi
city: Lake Success
country: United States
facility: ProHealthCARE Associates, LLP
state: New York
city: Portland
country: United States
facility: Northwest Cancer Specialists dba Compass Oncology
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists dba Compass Oncology
state: Oregon
city: Beaver
country: United States
facility: UPMC Cancer Center Beaver
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Cancer Center Arnold Palmer at Mountainview
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC Cancer Center Greenville
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Cancer Center Monroeville
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center St. Margarets
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center Passavant (HOA)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center Passavant (OHA)
state: Pennsylvania
city: Seneca
country: United States
facility: UPMC Cancer Center Northwest
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, P.C. d/b/a West Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology -Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: Fairfax
country: United States
facility: Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
state: Virginia
city: Reston
country: United States
facility: Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists dba Compass Oncology
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists dba Compass Oncology
state: Washington
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Calgary
country: Canada
facility: Holy Cross Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: SunnyBrook Research Institute
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hospital du Saint-Sacrement
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: