Spots Global Cancer Trial Database for Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
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Trial Identification
Brief Title: Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
Official Title: Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
Study ID: NCT03535506
Conditions
Interventions
Study Description
Brief Summary: This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study. There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients: 1. Group A, of male or female patients treated with palbociclib single agent (n=12); 2. Group B, untreated, of male or female patients who consented translational studies in blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative treatment with palbociclib (n=12).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Medstar Washington Hospital Center, Washington, District of Columbia, United States
Contact Details
Name: Candace Mainor, MD
Affiliation: Georgetown University
Role: PRINCIPAL_INVESTIGATOR
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