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

N/ANo Longer AvailableNCT02142868

Pfizer

Overview

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).

This study is currently available in Canada only.

Study Type

EXPANDED_ACCESS

Conditions

Advanced Breast Cancer (Female)

Interventions

PalbociclibDRUG

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)

LetrozoleDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (55)

Data from ClinicalTrials.gov

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

Bakersfield, California, United States

MedStar Georgetown University Hospital

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

Washington Cancer Institute at MedStar Washington Hospital Center

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

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

Duluth, Georgia, United States

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

Lawrenceville, Georgia, United States

Presence Saint Joseph Hospital

Chicago, Illinois, United States

North Shore Oncology-Hematology Associates, Ltd.

Crystal Lake, Illinois, 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

...and 45 more locations