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

Trial details

Who runs it

Washington University School of Medicine

Trial code

NCT07914309

Record updated

3 November 2026

Original description

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.Read full original descriptionShow less

STEROID-LITE: A Phase II Study Evaluating the Safety and Feasibility of Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer

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: 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 consent document.

Exclusion: Prior treatment with carboplatin; Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessments occurring during the study. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial; Active autoimmune disease for which they are currently receiving systemic steroid therapy or other form of immunosuppressive therapy. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal pituitary insufficiency) is not considered a form of systemic treatment; HIV-infected if not on effective anti-retroviral therapy with an undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of a known history of infection; History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of a known history of infection; A history of allergic reactions attributed to polyethoxylated castor oil-containing medications; Uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or active tuberculosis; Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of a known history of infection; Pregnant and/or breastfeeding.

ClinicalTrials.gov NCT07914309