33
Participants
Start Date
November 13, 2018
Primary Completion Date
March 30, 2026
Study Completion Date
June 30, 2026
Avelumab
Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.
Endocrine therapy
"The endocrine therapy given will depend on menopausal status.~Premenopausal women will receive tamoxifen AND either Goserelin or Leuprolide:~* Tamoxifen (20mg) will be given orally daily x 4 cycles. (Other Names: Nolvadex)~* Goserelin (3.6mg) will be given subcutaneously (under the skin) on Day 1 of each cycle x 4 cycles. (Other Names: Zoladex)~* Leuprolide (3.75mg) will be given intramuscularly (in the buttock, thigh, or upper arm) on Day 1 of each cycle x 4 cycles. (Other Names: Leuprorelin, Lupron, Eligard)~Postmenopausal women will receive letrozole:~\- Letrozole (2.5mg) will be given orally daily each cycle x 4 cycles. (Other Names: Femara)"
Palbociclib
Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.
Allegheny Health Network, Pittsburgh
Sibley Memorial Hospital, Washington D.C.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
University of Alabama at Birmingham, Birmingham
Collaborators (1)
Pfizer
INDUSTRY
Allegheny Health Network
OTHER
National Institutes of Health (NIH)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER