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NOT YET RECRUITING
NCT07914309
PHASE2

Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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

DRUG

Dexamethasone

Dexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.

DRUG

Famotidine

Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.

DRUG

Diphenhydramine

Diphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.

DRUG

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.

DRUG

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.

DRUG

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.

BIOLOGICAL

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.

DRUG

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.

DRUG

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