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Brief Title: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Official Title: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
Study ID: NCT05134922
Brief Summary: Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Detailed Description: The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Michigan, Ann Arbor, Michigan, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States