Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

NCT04722978 | Recruiting Phase 3 DMC

• 1 other identifier: SYSUCC-003
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  The interval from the date of randomization until the first date on which progression, or death due to any cause

  36 months

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Gemcitabine combined with carboplatin plus moxifloxacin

Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

Control group

PLACEBO COMPARATOR

Gemcitabine combined with carboplatin plus placebo

Drug: Gemcitabine combined with carboplatin plus placebo

Interventions

Gemcitabine combined with carboplatin plus placebo DRUG

Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Also known as: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Control group

Gemcitabine and carboplatin plus antibiotic (moxifloxacin) DRUG

Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)

Also known as: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
• Histologically confirmed invasive ductal carcinoma, no specific type (NOS)
• ER negative and progesterone receptor (PR) negative (defined as \< 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).
• No prior therapy after first recurrence or diagnosis of metastatic disease.
• At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.
• Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).
• Compliance with the study protocol.
• Have provided written and signed informed consent.

You may not qualify if:

• Pregnant or breast feeding.
• Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).
• Patients who are receiving or will receive other biological agents or immunotherapy.
• Uncontrolled medical problems.
• Evidence of active acute or chronic infection.
• Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.
• Concurrent malignancy or history of other malignancy within the last five years.
• Known severe hypersensitivity to moxifloxacin
• Patients were unable or unwilling to comply with program requirements.

Sponsors & Collaborators

• Sun Yat-Sen University Cancer Center: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Gemcitabine; Carboplatin; Anti-Bacterial Agents; Moxifloxacin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhong-yu Yuan, M.D.

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Zhong-yu Yuan, M.D.

CONTACT

862087342794; yuanzhy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Gemcitabine combined with carboplatin plus moxifloxacin or placebo

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (1)