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Not yet taking people in United StatesPhase 2

Using Less Dexamethasone During Pre-Surgery Chemotherapy and Immunotherapy for Triple-Negative Breast Cancer

Tests giving less dexamethasone to adults having treatment before surgery for triple-negative breast cancer.

Key facts

Who runs it
Washington University School of Medicine
Where
Kansas City and St Louis, United StatesSee the 2 sites
Trial code
Registry title
Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
People taking part
17 people, planned
Starts
30 Nov 2026
Expected to end
31 May 2033
Type of study
Interventional
Treatments tested
  • Dexamethasone
  • Famotidine
  • Diphenhydramine
  • Olanzapine
  • Paclitaxel
  • Carboplatin
  • Pembrolizumab
  • Doxorubicin
  • Cyclophosphamide
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with untreated, locally advanced triple-negative breast cancer that has not spread. They must plan to receive the standard KEYNOTE 522 treatment.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Confirmed, untreated, locally advanced, non-metastatic triple-negative breast cancer.
Earlier treatment
No earlier treatment of this cancer. No earlier carboplatin. Planning to receive the KEYNOTE 522 regimen as standard care.
Biomarker or test result
Triple-negative breast cancer (as confirmed on tissue or cell testing). ECOG performance status of 1 or lower.

Main reasons for not taking part

  • Earlier treatment with carboplatin
  • Pregnant or breastfeeding
  • Allergic reaction to medicines containing polyethoxylated castor oil
  • Active autoimmune disease treated with steroids or other immune-suppressing treatment
  • Uncontrolled illness, such as active infection, symptomatic heart failure, unstable angina, heart rhythm problems or active tuberculosis

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

  • St. Luke's HospitalKansas City, United StatesContact: Timothy Pluard, MDNo longer taking part
  • Washington University School of MedicineSt Louis, United StatesContact: Faisal Fa'ak, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Dexamethasone sparing supportive careTreatment being tested

    Patients will be enrolled prior to start of standard of care (SOC) neoadjuvant systemic therapy (NAST) which is the KEYNOTE 522 regimen consisting of four 21-day cycles of paclitaxel and carboplatin (Days 1, 8, 15) and pembrolizumab (Day 1), followed by four 14- or 21-day cycles of doxorubicin, cyclophosphamide, and pembrolizumab (all on Day 1). During the first 2 weeks of paclitaxel/carboplatin infusions, patients will receive standard premedication of dexamethasone IV, famotidine IV, and diphenhydramine IV, approximately 30 minutes before treatment. If no HSR occurs, dexamethasone will be discontinued for the remaining 10 weeks of paclitaxel/carboplatin infusions, while famotidine and diphenhydramine will be continued as per standard practice. For the remaining weeks of KEYNOTE 522, dexamethasone premedication will be replaced with olanzapine 5-10 mg PO on Days 1-4 of each cycle, to be given with an NK1 receptor antagonist and a 5-HT3 receptor agonist.

    Treatment: Dexamethasone, Famotidine, Diphenhydramine, Olanzapine, Paclitaxel, Carboplatin, Pembrolizumab, Doxorubicin, and Cyclophosphamide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Using Less Dexamethasone During Pre-Surgery Chemotherapy and Immunotherapy for Triple-Negative Breast CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026