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J1836 - IMMUNe MOdulation in Early Stage Estrogen Receptor Positive Breast Cancer treated with NeoADjuvant Avelumab, Palbociclib, and Tamoxifen: the ImmunoADAPT study
Protocol Number:
Phase II
Cesar Santa-Maria
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This study is being done to see if it is possible to evaluate the clinical response rates (cCR) of Avelumab with Tamoxifen versus Avelumab, Palbociclib and Tamoxifen. Immunotherapy has demonstrated significant benefit in numerous tumor types, however, responses in ER-positive breast cancer is low. Priming tumors, i.e. converting them into an “inflamed” phenotype, may bolster responses to immunotherapy. CDK4/6 inhibitors have already been demonstrated to recruit TILs, and thus may be an important primer for immunotherapies, but a better understanding of their biological effect on cancer-immune cell interactions is needed. This study will address the immune-modulating effects of palbociclib, and if these changes result in better responses when avelumab is added to treatment.
Men/Woman. 18 years of older. Stage 2-3 ER positive breast cancer. T1N+ tumors must have a breast tumor greater than 1.5cm.
Patients will be treated with tamoxifen (20mg PO daily) +/- palbociclib (125mg PO daily for 21 days, 7 days off ) for 1 cycle (1 cycle equal to 28 days) and undergo a repeat biopsy, MRI, and blood draw at Cycle 2, Day 1. Afterwards avelumab will be added to both arms. Avelumab will be administered 10mg/kg IV every 14 days (1 cycle equal to 2 doses equal to 28 days). Patients will be treated for 3 cycles of avelumab with tamoxifen +/- palbociclib (thus 4 cycles total, including run-in without avelumab). Patients will be treated so long as there is no clinical evidence of progression and therapy is tolerated. Patients who experience progressive disease (25% increase) of their tumor will cease study treatment and undergo end-of-study assessment (including repeat MRI) and surgery. Otherwise, patients completing all 4 cycles of therapy will undergo MRI and surgery.
Last Update
08/08/2020 05:02 AM