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Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Official title: A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Endocrine Therapy: The ImmunoADAPT Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2018-11-13
Completion Date
2026-12-30
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States