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Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer

NCT05114720•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.

Detailed Description

This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. The main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. This study is designed to recruit up to 520 subjects.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Have provided written and signed informed consent;
•2. Histologically confirmed invasive ductal carcinoma;
•3. Planned to received (neo)/adjuvant chemotherapy;
•4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
•5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
•6. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
•7. Compliance with the study protocol.

Exclusion Criteria

•1. Pregnant or breast feeding;
•2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
•3. Hypersensitivity to moxifloxacin or quinolones compounds;
•4. Concomitant with other antitumor therapies or participating in other clinical trials;
•5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease;
•6. Severe uncontrolled co-infection, or severe metabolic disorders;
•7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
•8. Poor compliance, unwillingness or inability to follow protocol to continue the study;
•9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

November 11, 2021

Primary Completion Date

November 27, 2025

Completion Date

November 27, 2025

Last Updated

December 17, 2025

Enrollment

559

ACTUAL participants

Conditions

Breast Cancer

Interventions

standard adjuvant chemotherapy plus moxifloxacin

DRUG

standard adjuvant chemotherapy plus placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Inclusion Criteria

Exclusion Criteria

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