At a glance
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T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 4 other interventions for Breast Adenocarcinoma and 12 related conditions. Active but no longer recruiting, targeting 46 participants across 4 sites.
Detailed Summary
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status. * Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy. * Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
Study Details
Timeline
Interventions
60 mg/m2 once every 2 weeks for 4 cycles.
cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles.
Paclitaxel 80 mg/m2 IV once weekly for 12 weeks.
carboplatin IV 1.5 area under curve (AUC) once weekly for 12 weeks.
Given IV
Given IV