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OncoMatch/Clinical Trials/NCT07362914

Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions

Is NCT07362914 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Dexamethasone (12mg d1) and Dexamethasone (2mg QD, d1-5,) for breast cancer.

Phase 3RecruitingFudan UniversityNCT07362914Data as of May 2026

Treatment: Dexamethasone (12mg d1) · Dexamethasone (2mg QD, d1-5,) · Doxorubicin hydrochloride liposome · CyclophosphamideInvestigating 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: chemotherapy

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: radiotherapy

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: biologics

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: targeted therapy

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: immunotherapy

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: antitumor treatments

Exception: washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy)

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).

Cannot have received: liposomal doxorubicin or similar formulations

Previous treatment with liposomal doxorubicin or similar formulations.

Lab requirements

Blood counts

ANC ≥1.5 × 10⁹/L, Platelet count ≥75 × 10⁹/L, Hemoglobin ≥90 g/L

Kidney function

Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min

Liver function

Non-liver metastasis: TBIL ≤1.5 × ULN, ALT and AST ≤2.5 × ULN; Liver metastasis: TBIL ≤1.5 × ULN, ALT and AST ≤5 × ULN

Cardiac function

LVEF >50%, no severe arrhythmias/conduction abnormalities, no history of myocardial infarction, CABG, or heart failure (NYHA Class ≥II), QTcF ≤450 ms (males), ≤470 ms (females)

Hematologic: ANC ≥1.5 × 10⁹/L, Platelet count ≥75 × 10⁹/L, Hemoglobin ≥90 g/L; Hepatic: Non-liver metastasis: TBIL ≤1.5 × ULN, ALT and AST ≤2.5 × ULN; Liver metastasis: TBIL ≤1.5 × ULN, ALT and AST ≤5 × ULN; Renal: Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min; Coagulation: INR or PT ≤1.5 × ULN, APTT ≤1.5 × ULN; Cardiac: LVEF >50%, no severe arrhythmias/conduction abnormalities, no history of myocardial infarction, CABG, or heart failure (NYHA Class ≥II), QTcF ≤450 ms (males), ≤470 ms (females)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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