60
Participants
Start Date
October 25, 2016
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Palbociclib
Palbociclib will be given orally, continued at the same dose as was received previously; the maximum starting dose will be per the approved label, a dose of 125 mg once daily. Palbociclib will be taken days 1-21, then seven days off treatment to complete one 28 day cycle.
Fulvestrant
Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, and 29 (i.e., Cycle 2 Day 1) and once monthly thereafter (i.e., day 1 of each cycle).
Allegheny Health Network (AHN) - Allegheny General Hospital ONLY, Pittsburgh
Reading Hospital - McGlinn Cancer Institute, West Reading
Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital, Washington D.C.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
Anne Arundel Health System Research Institute, Inc., Annapolis
Collaborators (1)
Pfizer
INDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER