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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is currently available in Canada only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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