Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

November 13, 2018

Primary Completion Date

March 30, 2026

Study Completion Date

June 30, 2026

Conditions
Breast Cancer
Interventions
DRUG

Avelumab

Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.

DRUG

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)"

DRUG

Palbociclib

Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.

Trial Locations (4)

15224

Allegheny Health Network, Pittsburgh

20016

Sibley Memorial Hospital, Washington D.C.

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

35233

University of Alabama at Birmingham, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Allegheny Health Network

OTHER

collaborator

National Institutes of Health (NIH)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER