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

• Conditions: Advanced Breast Cancer (Female)

• Registration Number: NCT02142868
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (45)

Presence Saint Joseph Hospital; 🇺🇸 Chicago, Illinois, United States

Presence Infusion Care - Skokie; 🇺🇸 Skokie, Illinois, United States

SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building; 🇺🇸 Baltimore, Maryland, United States

Mount Nittany Medical Center; 🇺🇸 State College, Pennsylvania, United States

UPMC Cancer Center St. Margarets; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Cancer Center Passavant (OHA); 🇺🇸 Pittsburgh, Pennsylvania, United States

Texas Oncology -Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

SunnyBrook Research Institute; 🇨🇦 Toronto, Ontario, Canada

CHU de Quebec - Hospital du Saint-Sacrement; 🇨🇦 Quebec, Canada

CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center; 🇺🇸 Bakersfield, California, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Washington Cancer Institute at MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care; 🇺🇸 Lawrenceville, Georgia, United States

North Shore Oncology-Hematology Associates, Ltd.; 🇺🇸 Libertyville, Illinois, United States

Presence Medical Group Hematology Oncology; 🇺🇸 Northbrook, Illinois, United States

Illinois CancerCare, P.C.; 🇺🇸 Peoria, Illinois, United States

Metairie Oncologist, LLC; 🇺🇸 Metairie, Louisiana, United States

SKCCC at Johns Hopkins, Green Spring Station; 🇺🇸 Lutherville, Maryland, United States

The West Clinic, P.C.; 🇺🇸 Corinth, Mississippi, United States

The West Clinic, P.C. d/b/a West Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Northwest Cancer Specialists dba Compass Oncology; 🇺🇸 Vancouver, Washington, United States

UPMC Cancer Center Beaver; 🇺🇸 Beaver, Pennsylvania, United States

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Cancer Center Arnold Palmer at Mountainview; 🇺🇸 Greensburg, Pennsylvania, United States

UPMC Cancer Center Greenville; 🇺🇸 Greenville, Pennsylvania, United States

UPMC Cancer Center Passavant (HOA); 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Cancer Center Northwest; 🇺🇸 Seneca, Pennsylvania, United States

Texas Oncology - Memorial City; 🇺🇸 Houston, Texas, United States

Medical Oncology & Hematology Associates of Northern Virginia, Ltd.; 🇺🇸 Reston, Virginia, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Holy Cross Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Sunnybrook health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre; 🇨🇦 Montreal, Quebec, Canada

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Jackson Oncology Associates, PLLC; 🇺🇸 Jackson, Mississippi, United States

Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Mississippi Baptist Health Systems; 🇺🇸 Jackson, Mississippi, United States

ProHealthCARE Associates, LLP; 🇺🇸 Lake Success, New York, United States

UPMC Cancer Center Monroeville; 🇺🇸 Monroeville, Pennsylvania, United States