Steroids may ease painful skin side effect of breast cancer chemo
NCT ID NCT07362914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial is testing whether the corticosteroid dexamethasone can reduce hand-foot syndrome—a painful skin reaction—caused by liposomal doxorubicin chemotherapy in breast cancer patients. 182 participants will receive either high-dose, standard-dose, or no dexamethasone alongside their chemo. The goal is to see if steroids can make treatment more tolerable without affecting cancer control.
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 corticosteroid)
- What this could lead to
- If it works, this could offer a simple way to prevent painful hand-foot skin reactions during chemotherapy, improving quality of life for breast cancer patients.
- What could go wrong
- This is a phase 3 trial, but it is still early to know if the benefit is real. Corticosteroids have side effects like infection risk and high blood sugar, and the study is relatively small (182 people).
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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 182 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2027
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 to 70 years
- 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. Patients aged 18-70 years (inclusive), regardless of gender. 2. Diagnosis \& Treatment Plan: Histopathologically confirmed early-stage or advanced breast cancer patients eligible for AC regimen (liposomal doxorubicin + cyclophosphamide) chemotherapy per clinical guidelines. 3. ECOG Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. 4. Anticipated survival ≥3 months. 5. Organ Function Requirements: Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L ,Platelet count ≥75 × 10⁹/L Hemoglobin ≥90 g/L Hepatic: Non-liver metastasis: Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN Liver metastasis: TBIL ≤1.5 × ULN ,ALT and AST ≤5 × ULN Renal: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (Ccr) ≥50 mL/min Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN Activated partial thromboplastin time (APTT) ≤1.5 × ULN 6. Contraception: Female patients: Must use effective contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum pregnancy test within 7 days prior to enrollment is required, and patients must be non-lactating. Male patients: Must agree to use contraception during the study and for 6 months after study completion. 7. Informed Consent: Patients must voluntarily participate, provide signed informed consent, and comply with protocol-specified procedures (blood tests, follow-ups, etc.). Exclusion Criteria: 1. Received chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first study dose (or within 5 half-lives, whichever is shorter). Exceptions: The washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy to avoid prolonged patient waiting). 2. Previous treatment with liposomal doxorubicin or similar formulations. 3. Allergy History: Known hypersensitivity to liposomal products or doxorubicin. 4. Cardiovascular Diseases: Severe arrhythmias/conduction abnormalities (e.g., clinically significant ventricular arrhythmias, second- or third-degree AV block). History of myocardial infarction, coronary artery bypass grafting (CABG), or heart failure (NYHA Class ≥II). LVEF ≤50%or prolonged QTcF (\>450 ms in males; \>470 ms in females). 5. Active Infections: Grade ≥2 (NCI CTCAE v5.0) 6. Immunosuppression: Active autoimmune diseases, immunodeficiency (e.g., HIV-positive), or congenital/acquired immune disorders. History of organ transplantation or chronic corticosteroid use. 7. HBsAg-positive with HBV-DNA ≥500 IU/mL. Exception: If HBV-DNA \<500 IU/mL and chronic hepatitis is deemed stable/inactive by the investigator, enrollment is permitted. 8. Other Infections: Positive for HCV antibody or syphilis-specific antibody. 9. Neurological/Psychiatric Disorders: History of epilepsy, dementia, or other uncontrolled conditions. 10. CNS Metastases: Symptomatic brain or leptomeningeal metastases, or uncontrolled CNS lesions. Exception: Asymptomatic brain metastases or lesions stable for ≥28 days without steroids/antitumor therapy are allowed. 11. Any other condition that, per investigator assessment, may compromise patient safety or study compliance. 12. Pregnant or breastfeeding women. 13. Patients deemed ineligible for the study by the investigator.
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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
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
Contact Email: •••••@•••••
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