Can a common steroid shield breast cancer patients from a dangerous drug side effect?
NCT ID NCT07828054
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Trastuzumab deruxtecan (T-DXd) treats metastatic breast cancer but can cause interstitial lung disease (ILD), a form of lung inflammation that sometimes forces patients to stop treatment. Researchers are testing whether giving dexamethasone before each T-DXd infusion lowers the chance of developing ILD. The trial enrolls about 244 adults with metastatic breast cancer who are starting T-DXd. Participants receive either dexamethasone plus standard anti-nausea premedication or standard premedication alone, and researchers track lung changes on CT scans over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamethasone, a steroid given before trastuzumab deruxtecan infusions
- What this could lead to
- If it works, dexamethasone premedication could let more people stay on trastuzumab deruxtecan without developing serious lung inflammation.
- What could go wrong
- The trial may show dexamethasone does not lower lung inflammation risk, or that any benefit comes with steroid side effects. Results may not apply to all breast cancer treatment settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 244 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed, written and dated study informed consent, data protection informed consent and any locally required 2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. 3. Histologically or cytologically confirmed metastatic breast cancer for which T-DXd treatment is approved and available at the participating center. 4. Diagnosis of metastatic breast cancer candidate to start a treatment with T-DXd in the subsequent settings: 1. HR-positive with expression of HER2 (low or ultralow) ≤ 2 lines of chemotherapy in advanced disease 2. HR-negative with expression of HER2-low ≤ 2 lines of chemotherapy in advanced disease 3. HER2-positive independently from HR-positivity ≤ 3 lines of treatment in advanced disease 5. ECOG performance status of 0 or 1. 6. Adequate bone marrow as defined by the following laboratory values: 1. ANC ≥1.5 × 109 /L 2. Platelets ≥100 × 109 /L 3. Hemoglobin ≥9.0 g/dL 7. Adequate hepatic function: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN (≤ 5 in patients with liver metastases); international normalized ratio (INR) \< 1.5. 8. Adequate washout before randomization, including ≥4 weeks from major surgery or chest radiotherapy (≥2 weeks for non-chest stereotactic radiotherapy) 9. Patient willing and able to comply with the protocol procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up. Exclusion Criteria: 1. Patients with uncontrolled diabetes mellitus both type 1 and type 2 (HbA1c \> 8.5%). 2. Patients with contraindications to dexamethasone, as determined by the investigator in consultation with medical monitoring before enrolment. 3. Patients already undergoing chronic steroid treatment (e.g. 10 mg/day of prednisone/prednisolone or equivalent). 4. Patients requiring oxygen therapy at rest. 5. Documented pneumonitis/ILD prior to Cycle 1 Day 1. 6. Uncontrolled or significant cardiovascular disease, including recent myocardial infarction (within 6 months), symptomatic heart failure (NYHA II-IV), elevated troponin without symptoms requiring cardiology evaluation, uncontrolled hypertension or arrhythmias, and QTcF prolongation \>470 ms in females or \>450 ms in males. 7. Impaired renal function with creatinine clearance \<30 mL/min (calculated by Cockcroft-Gault formula). 8. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. 9. Patients with recent (\<28 days) respiratory infections. 10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impacts the absorption of the study drug. 11. Palliative limited-field radiotherapy: \<2 weeks (non-chest) or \<4 weeks (chest or \>30% bone marrow). 12. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 390 days after the last dose of IMP. 13. Active and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 14. Evidence of ongoing alcohol or drug abuse as assessed by the Investigator. 15. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the patient's participation in a clinical study 16. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during study participation. Female subjects without childbearing potential are defined as women who are surgically sterile (hysterectomy or documented bilateral tubal ligation) or postmenopausal, defined as at least 12 months of spontaneous amenorrhea. 17. Known allergy or hypersensitivity to study drugs or any excipient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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