Actively Recruiting
Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions
Led by Fudan University · Updated on 2026-01-23
182
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Investigating the Association Between Corticosteroid Use and Improvement in Doxorubicin Liposome-Induced Cutaneous Toxicity: Exploring the Feasibility and Mechanisms of Corticosteroids in Mitigating Liposomal Doxorubicin-Related Dermatologic Adverse Effects.
CONDITIONS
Official Title
Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years (inclusive), any gender
- Histopathologically confirmed early-stage or advanced breast cancer eligible for AC regimen chemotherapy (liposomal doxorubicin + cyclophosphamide)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function: hematologic, hepatic, renal, and coagulation parameters within specified limits
- Female patients must use effective contraception during the study and for 6 months after, have a negative pregnancy test within 7 days prior to enrollment, and be non-lactating
- Male patients must agree to use contraception during the study and for 6 months after
- Voluntary informed consent and willingness to comply with study procedures
You will not qualify if you...
- Received chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, or other antitumor treatments within 4 weeks before first study dose (exceptions allowed by investigator)
- Prior treatment with liposomal doxorubicin or similar formulations
- Known hypersensitivity to liposomal products or doxorubicin
- Severe cardiovascular diseases including serious arrhythmias, history of myocardial infarction, coronary artery bypass grafting, heart failure (NYHA Class II or higher), low left ventricular ejection fraction, or prolonged QTcF
- Active infections grade 2 or higher
- Active autoimmune diseases, immunodeficiency (e.g., HIV), history of organ transplantation, or chronic corticosteroid use
- Hepatitis B surface antigen positive with high HBV-DNA levels unless stable chronic hepatitis as deemed by investigator
- Positive for hepatitis C antibody or syphilis antibody
- History of epilepsy, dementia, or other uncontrolled neurological or psychiatric disorders
- Symptomatic brain or leptomeningeal metastases or uncontrolled central nervous system lesions (exceptions for stable or asymptomatic brain metastases)
- Any other condition that may compromise patient safety or study compliance as judged by investigator
- Pregnant or breastfeeding women
- Patients deemed ineligible by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang, MD, PhD
CONTACT
Y
Yanchun Meng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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