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OncoMatch/Clinical Trials/NCT07362914

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

Is NCT07362914 recruiting? Yes, currently enrolling (Jun 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 Jun 2026Location: China

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

Treatments studied

Chemotherapy

Doxorubicin hydrochloride liposomeCyclophosphamide

Other

Dexamethasone (12mg d1)Dexamethasone (2mg QD, d1-5,)

Cancer type

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT07362914 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, radiotherapy, biologics disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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