Breast CancerPhase 3CHORDNCT07362914
Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions
A Phase 3 study testing Dexamethasone (12mg d1), Dexamethasone (2mg QD, d1-5,) and Doxorubicin hydrochloride liposome injection in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dexamethasone (12mg d1), Dexamethasone (2mg QD, d1-5,) and Doxorubicin hydrochloride liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2025to 30 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Informed Consent: Patients must voluntarily participate, provide signed informed consent, and comply with protocol-specified procedures (blood tests, follow-ups, etc.).
Who cannot join
- 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).
Show all 18Show fewer
- 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.
- Any other condition that, per investigator assessment, may compromise patient safety or study compliance.
- Pregnant or breastfeeding women.
- Patients deemed ineligible for the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, MD,PhD, +8664175590 ext. 85000, syner2000@163.com
Yanchun Meng, MD, +8664175590 ext. 63028, ycmclinicaltrials@126.com
About this study
Official title: The Role of Corticosteroids in Hand & Foot & Skin Reactions Reduction to Doxorubicin Liposomes
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.
Read the detailed description
Background
Liposomal doxorubicin exhibits distinct toxicity profiles compared to free-form doxorubicin in clinical practice. Cutaneous toxicity represents the primary dose-limiting adverse effect of liposomal doxorubicin, with incidence and severity demonstrating a dose-dependent relationship . Current management strategies-including dose reduction or extended treatment intervals-yield limited efficacy, often leading to treatment discontinuation due to intolerable symptoms, thereby compromising clinical utility.
Mechanistic Insights
Our preliminary research identified neutrophils as key mediators in liposomal skin accumulation:
Complement receptor 3 (CR3) recognizes iC3b deposited on liposomes via complement activation.
Neutrophils phagocytose liposomes and extravasate into cutaneous tissues, driving drug accumulation.
Intervention with complement inhibitors significantly reduced liposomal doxorubicin deposition in murine skin by:
Blocking complement activation Decreasing iC3b opsonization Inhibiting neutrophil-mediated uptake.
Clinical Evidence
A retrospective study at our center demonstrated that corticosteroid pretreatment alleviated liposomal doxorubicin-induced hand-foot syndrome (HFS) in a dose-dependent manner :
High-dose corticosteroids limited Grade 1 HFS to <10% of patients16. Findings support complement inhibition as a viable strategy for mitigating cutaneous toxicity7.
Study Objectives
This prospective study aims to:
Correlate corticosteroid use with HFS severity reduction in liposomal doxorubicin therapy.
- Conditions
- Breast Cancer
- Being tested
- Dexamethasone (12mg d1), Dexamethasone (2mg QD, d1-5,), Doxorubicin hydrochloride liposome injection, Cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (12mg d1)Drug
dexamethasone 12mg d1, PO/IV;
Dexamethasone (2mg QD, d1-5,)Drug
dexamethasone 12mg QD, d1-5, PO/IV.
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).
CyclophosphamideDrug
Cyclophosphamide 600 mg/m² administered by intravenous infusion every 2 weeks (q2w) or every 3 weeks (q3w).
| Study group | Role | What they receive |
|---|---|---|
| Arm A(NEO-DXMS GROUP) | Experimental | no dexamethasone Receives: Drug: Doxorubicin hydrochloride liposome injection; Drug: Cyclophosphamide |
| Arm B( MED-DEX GROUP ) | Experimental | dexamethasone 12mg d1, PO/IV Receives: Drug: Dexamethasone (12mg d1); Drug: Doxorubicin hydrochloride liposome injection; Drug: Cyclophosphamide |
| Arm C(HIGH-DEX GROUP ) | Experimental | dexamethasone 12mg QD, d1-5, PO/IV Receives: Drug: Dexamethasone (2mg QD, d1-5,); Drug: Doxorubicin hydrochloride liposome injection; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 17 months
Secondary outcomes (4)
ncidence of Treatment-Emergent Adverse Events
Standardized terminology for dermatologic adverse events, typically graded per CTCAE (Common Terminology Criteria for Adverse Events) v5.0 criteria
Measured: 17 months
Disease-free survival (DFS)
Defined as the time from randomization (or treatment initiation in single-arm trials) to disease recurrence or death from any cause.
Measured: 17 months
Progression-free survival (PFS)
The duration from treatment initiation to tumor progression (per RECIST 1.1 ) or death.
Measured: 17 months
Overall survival (OS)
Time from randomization to death from any cause
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start7 Mar 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362914
- Sponsor's protocol ID
- 2412310-10
- Acronym
- CHORD
- Status last verified
- Jan 2026
- First submitted
- 11 May 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Corticosteroids in Hand & Foot & Skin Reactions Reduction to Doxorubicin Liposomes
- ClinicalTrials.gov ID
- NCT07362914
- Acronym / sponsor ID
- CHORD / 2412310-10
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Liposomal doxorubicin exhibits distinct toxicity profiles compared to free-form doxorubicin in clinical practice. Cutaneous toxicity represents the primary dose-limiting adverse effect of liposomal doxorubicin, with incidence and severity demonstrating a dose-dependent relationship . Current management strategies-including dose reduction or extended treatment intervals-yield limited efficacy, often leading to treatment discontinuation due to intolerable symptoms, thereby compromising clinical utility.
Mechanistic Insights
Our preliminary research identified neutrophils as key mediators in liposomal skin accumulation:
Complement receptor 3 (CR3) recognizes iC3b deposited on liposomes via complement activation.
Neutrophils phagocytose liposomes and extravasate into cutaneous tissues, driving drug accumulation.
Intervention with complement inhibitors significantly reduced liposomal doxorubicin deposition in murine skin by:
Blocking complement activation Decreasing iC3b opsonization Inhibiting neutrophil-mediated uptake.
Clinical Evidence
A retrospective study at our center demonstrated that corticosteroid pretreatment alleviated liposomal doxorubicin-induced hand-foot syndrome (HFS) in a dose-dependent manner :
High-dose corticosteroids limited Grade 1 HFS to <10% of patients16. Findings support complement inhibition as a viable strategy for mitigating cutaneous toxicity7.
Study Objectives
This prospective study aims to:
Correlate corticosteroid use with HFS severity reduction in liposomal doxorubicin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A(NEO-DXMS GROUP) | Experimental | Drug: Doxorubicin hydrochloride liposome injection, Drug: Cyclophosphamideno dexamethasone |
| Arm B( MED-DEX GROUP ) | Experimental | Drug: Dexamethasone (12mg d1), Drug: Doxorubicin hydrochloride liposome injection, Drug: Cyclophosphamidedexamethasone 12mg d1, PO/IV |
| Arm C(HIGH-DEX GROUP ) | Experimental | Drug: Dexamethasone (2mg QD, d1-5,), Drug: Doxorubicin hydrochloride liposome injection, Drug: Cyclophosphamidedexamethasone 12mg QD, d1-5, PO/IV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone (12mg d1)dexamethasone 12mg d1, PO/IV; | Drug | Arm B( MED-DEX GROUP ) |
| Dexamethasone (2mg QD, d1-5,)dexamethasone 12mg QD, d1-5, PO/IV. | Drug | Arm C(HIGH-DEX GROUP ) |
| Doxorubicin hydrochloride liposome injectionLiposomal doxorubicin at a dose of 35 mg/m², given via intravenous (IV) infusion every 2 weeks (q2w) or every 3 weeks (q3w). | Drug | Arm A(NEO-DXMS GROUP), Arm B( MED-DEX GROUP ), Arm C(HIGH-DEX GROUP ) |
| CyclophosphamideCyclophosphamide 600 mg/m² administered by intravenous infusion every 2 weeks (q2w) or every 3 weeks (q3w). | Drug | Arm A(NEO-DXMS GROUP), Arm B( MED-DEX GROUP ), Arm C(HIGH-DEX GROUP ) |
Primary outcome
Number of participants with hand-foot syndrome (HFS) as assessed by CTCAE v5.0 in the high-dose dexamethasone group
Time frame: 17 months
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)
4 secondary outcomes
ncidence of Treatment-Emergent Adverse Events
Time frame: 17 months
Disease-free survival (DFS)
Time frame: 17 months
Progression-free survival (PFS)
Time frame: 17 months
Overall survival (OS)
Time frame: 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone (12mg d1), Dexamethasone (2mg QD, d1-5,) and Doxorubicin hydrochloride liposome injection in people with Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, MD, PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with hand-foot syndrome (HFS) as assessed by CTCAE v5.0 in the high-dose dexamethasone group (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.