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Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
Sponsor: Washington University School of Medicine
Summary
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.
Official title: STEROID-LITE: A Phase II Study Evaluating the Safety and Feasibility of Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2026-11-30
Completion Date
2033-05-31
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Dexamethasone
Dexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.
Famotidine
Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.
Diphenhydramine
Diphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.
Olanzapine
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
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
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
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
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
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.
Locations (2)
St. Luke's Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States