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

NCT04722978 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DRUG

Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

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

DRUG

Gemcitabine combined with carboplatin plus placebo

Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Zhong-yu Yuan, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722978 on ClinicalTrials.gov