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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

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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This study is currently available in Canada only.

Conditions

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Advanced Breast Cancer (Female)

Keywords

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Expanded Access Advanced Breast Cancer

Interventions

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Palbociclib

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)

Intervention Type DRUG

Letrozole

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.

Intervention Type DRUG

Other Intervention Names

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Ibrance Femara

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center

Bakersfield, California, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care

Duluth, Georgia, United States

Site Status

Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care

Lawrenceville, Georgia, United States

Site Status

Presence Saint Joseph Hospital

Chicago, Illinois, United States

Site Status

North Shore Oncology-Hematology Associates, Ltd.

Crystal Lake, Illinois, United States

Site Status

North Shore Oncology-Hematology Associates, Ltd.

Libertyville, Illinois, United States

Site Status

Presence Medical Group Hematology Oncology

Northbrook, Illinois, United States

Site Status

Illinois CancerCare, P.C.

Peoria, Illinois, United States

Site Status

Presence Infusion Care - Skokie

Skokie, Illinois, United States

Site Status

Metairie Oncologist, LLC

Metairie, Louisiana, United States

Site Status

SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building

Baltimore, Maryland, United States

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SKCCC at Johns Hopkins, Green Spring Station

Lutherville, Maryland, United States

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The West Clinic, P.C.

Corinth, Mississippi, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

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Mississippi Baptist Health Systems

Jackson, Mississippi, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

The West Clinic, P.C. d/b/a West Cancer Center

Southaven, Mississippi, United States

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ProHealthCARE Associates, LLP

Lake Success, New York, United States

Site Status

Northwest Cancer Specialists dba Compass Oncology

Portland, Oregon, United States

Site Status

Northwest Cancer Specialists dba Compass Oncology

Portland, Oregon, United States

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UPMC Cancer Center Beaver

Beaver, Pennsylvania, United States

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UPMC Cancer Center Arnold Palmer at Mountainview

Greensburg, Pennsylvania, United States

Site Status

UPMC Cancer Center Greenville

Greenville, Pennsylvania, United States

Site Status