Washington University School of Medicine
This is a single-arm, open-label, phase II trial designed to prospectively evaluate the safety and feasibility of dexamethasone de-escalation in patients undergoing standard neoadjuvant chemotherapy and immunotherapy for triple negative breast cancer.
Inclusion Criteria: * Histologically or cytologically confirmed, untreated, locally advanced, non-metastatic triple-negative breast cancer. * Planning to receive the KEYNOTE 522 regimen as per standard of care. * At least 18 years of age. * ECOG performance status ≤ 1 * People of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of any of the KEYNOTE 522 drugs. * Ability to understand and willingness to sign an IRB-approved written informed conse…
Dexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.
Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.
Diphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.
Olanzapine will be administered orally at a dose of 5-10 mg 30 minutes prior to treatment of the KEYNOTE 522 regimen. Administration of olanzapine will occur on Day 1 and Day 4 of the 21-day cycles. Olanzapine will be administered the from weeks 3-14 of the KEYSTONE 522 regimen.
Paclitaxel will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.
Carboplatin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Carboplatin will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.
Pembrolizumab will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Day 1 of Cycles 1-8. Each cycle is 21 days in length.
Doxorubicin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Doxorubicin will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.
Cyclophosphamide will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Cyclophosphamide will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.
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