NCT07362914

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
9mo left

Started Mar 2025

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2025Jan 2027

Study Start

First participant enrolled

March 7, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

May 11, 2025

Last Update Submit

January 14, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with hand-foot syndrome (HFS) as assessed by CTCAE v5.0 in the high-dose dexamethasone group

    Compared to both the no-dexamethasone group and the standard-dose dexamethasone group, the high-dose dexamethasone group demonstrated reduced incidence of hand-foot syndrome (HFS)

    17 months

Secondary Outcomes (4)

  • ncidence of Treatment-Emergent Adverse Events

    17 months

  • Disease-free survival (DFS)

    17 months

  • Progression-free survival (PFS)

    17 months

  • Overall survival (OS)

    17 months

Study Arms (3)

Arm A(NEO-DXMS GROUP)

EXPERIMENTAL

no dexamethasone

Drug: Doxorubicin hydrochloride liposome injectionDrug: Cyclophosphamide

Arm B( MED-DEX GROUP )

EXPERIMENTAL

dexamethasone 12mg d1, PO/IV

Drug: Dexamethasone (12mg d1)Drug: Doxorubicin hydrochloride liposome injectionDrug: Cyclophosphamide

Arm C(HIGH-DEX GROUP )

EXPERIMENTAL

dexamethasone 12mg QD, d1-5, PO/IV

Drug: Dexamethasone (2mg QD, d1-5,)Drug: Doxorubicin hydrochloride liposome injectionDrug: Cyclophosphamide

Interventions

Dexamethasone (12mg d1)DRUG

dexamethasone 12mg d1, PO/IV;

Arm B( MED-DEX GROUP )
Dexamethasone (2mg QD, d1-5,)DRUG

dexamethasone 12mg QD, d1-5, PO/IV.

Arm C(HIGH-DEX GROUP )
Doxorubicin hydrochloride liposome injectionDRUG

Liposomal doxorubicin at a dose of 35 mg/m², given via intravenous (IV) infusion every 2 weeks (q2w) or every 3 weeks (q3w).

Arm A(NEO-DXMS GROUP)Arm B( MED-DEX GROUP )Arm C(HIGH-DEX GROUP )
CyclophosphamideDRUG

Cyclophosphamide 600 mg/m² administered by intravenous infusion every 2 weeks (q2w) or every 3 weeks (q3w).

Arm A(NEO-DXMS GROUP)Arm B( MED-DEX GROUP )Arm C(HIGH-DEX GROUP )

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70 years (inclusive), regardless of gender.
  • Diagnosis \& Treatment Plan: Histopathologically confirmed early-stage or advanced breast cancer patients eligible for AC regimen (liposomal doxorubicin + cyclophosphamide) chemotherapy per clinical guidelines.
  • ECOG Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Anticipated survival ≥3 months.
  • 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
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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).
  • Previous treatment with liposomal doxorubicin or similar formulations.
  • Allergy History: Known hypersensitivity to liposomal products or doxorubicin.
  • 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).
  • Active Infections: Grade ≥2 （NCI CTCAE v5.0）
  • Immunosuppression:
  • Active autoimmune diseases, immunodeficiency (e.g., HIV-positive), or congenital/acquired immune disorders.
  • History of organ transplantation or chronic corticosteroid use.
  • 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.
  • Other Infections: Positive for HCV antibody or syphilis-specific antibody.
  • Neurological/Psychiatric Disorders: History of epilepsy, dementia, or other uncontrolled conditions.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DexamethasoneCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Jian Zhang, MD, PhD

CONTACT

+8664175590syner2000@163.com

Yanchun Meng, MD

CONTACT

+8664175590ycmclinicaltrials@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

May 11, 2025

First Posted

January 23, 2026

Study Start

March 7, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)