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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Female
- Target Recruitment
- Not specified
- 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)
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
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
Presence Saint Joseph Hospital
🇺🇸Chicago, 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
Presence Infusion Care - Skokie
🇺🇸Skokie, Illinois, United States
Metairie Oncologist, LLC
🇺🇸Metairie, Louisiana, United States
Scroll for more (35 remaining)CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center🇺🇸Bakersfield, California, United States