RecruitingPhase 3NCT04722978

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

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial


Sponsor

Sun Yat-Sen University Cancer Center

Enrollment

228 participants

Start Date

Apr 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the antibiotic moxifloxacin to standard chemotherapy (nab-paclitaxel and gemcitabine) improves treatment outcomes for metastatic triple-negative breast cancer — an aggressive form of breast cancer that lacks the three most common receptors targeted by existing therapies. **You may be eligible if:** - You have been diagnosed with metastatic triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - You have not yet received any treatment for metastatic disease - You have at least one measurable tumor - Your blood counts and organ function (kidneys, liver, heart) are adequate - Your white blood cell-to-lymphocyte ratio (NLR) is 2 or higher in blood tests **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have a confirmed BRCA mutation, high PD-L1 expression, or high microsatellite instability (MSI-H) - You are already receiving other biologic or immunotherapy treatments - You have a serious allergy to moxifloxacin - You have another active cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine and carboplatin plus antibiotic (moxifloxacin)

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

DRUGGemcitabine combined with carboplatin plus placebo

Standard chemotherapy (gemcitabine and carboplatin) plus placebo


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT04722978


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