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

December 20, 2018 updated by: Pfizer

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

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).

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This study is currently available in Canada only.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1S 4L8
        • CHU de Quebec - Hospital du Saint-Sacrement
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Calgary, Alberta, Canada, T2S 3C3
        • Holy Cross Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at MedStar Washington Hospital Center
    • Georgia
      • Duluth, Georgia, United States, 30096
        • Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
      • Lawrenceville, Georgia, United States, 30046
        • Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Presence Saint Joseph Hospital
      • Crystal Lake, Illinois, United States, 60014
        • North Shore Oncology-Hematology Associates, Ltd.
      • Libertyville, Illinois, United States, 60048
        • North Shore Oncology-Hematology Associates, Ltd.
      • Northbrook, Illinois, United States, 60062
        • Presence Medical Group Hematology Oncology
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, P.C.
      • Skokie, Illinois, United States, 60077
        • Presence Infusion Care - Skokie
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Metairie Oncologist, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
      • Lutherville, Maryland, United States, 21093
        • SKCCC at Johns Hopkins, Green Spring Station
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • The West Clinic, P.C.
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
      • Jackson, Mississippi, United States, 39216
        • Jackson Oncology Associates, PLLC
      • Jackson, Mississippi, United States, 39202
        • Mississippi Baptist Health Systems
      • Southaven, Mississippi, United States, 38671
        • The West Clinic, P.C. d/b/a West Cancer Center
    • New York
      • Lake Success, New York, United States, 11042
        • ProHEALTHCARE Associates, LLP
    • Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists dba Compass Oncology
      • Portland, Oregon, United States, 97225
        • Northwest Cancer Specialists dba Compass Oncology
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • UPMC Cancer Center Beaver
      • Greensburg, Pennsylvania, United States, 15601
        • UPMC Cancer Center Arnold Palmer at Mountainview
      • Greenville, Pennsylvania, United States, 16125
        • UPMC Cancer Center Greenville
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC Cancer Center Monroeville
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15215
        • UPMC Cancer Center St. Margarets
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Cancer Center Passavant (HOA)
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Cancer Center Passavant (OHA)
      • Seneca, Pennsylvania, United States, 16346
        • UPMC Cancer Center Northwest
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, P.C. d/b/a West Cancer Center
      • Memphis, Tennessee, United States, 38104
        • The West Clinic, P.C. d/b/a West Cancer Center
      • Memphis, Tennessee, United States, 38120
        • The West Clinic, P.C. d/b/a West Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology -Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
      • Reston, Virginia, United States, 20190
        • Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Vancouver, Washington, United States, 98683
        • Northwest Cancer Specialists dba Compass Oncology
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists dba Compass Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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