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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: standard adjuvant chemotherapy plus moxifloxacin; Drug: standard adjuvant chemotherapy plus 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.

• Study Type: Interventional
• Enrollment (Actual): 559
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard adjuvant chemotherapy plus moxifloxacin; Standard adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus antibiotic (moxifloxacin) Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1, cycled every 21 days cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days	Drug: standard adjuvant chemotherapy plus moxifloxacin; docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1 cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m^2, IV, days 1, cycled every 21 days; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days; Other Names: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus antibiotic (moxifloxacin)
Placebo Comparator: standard adjuvant chemotherapy plus placebo; Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1 cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days	Drug: standard adjuvant chemotherapy plus placebo; docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1 cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m^2, IV, days 1, cycled every 21 days; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days; Other Names: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival (DFS)	The interval from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death due to any cause	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	The interval from the date of randomization until the first date on death due to any cause, or the last follow-up time	10 years
distant disease-free survival (DDFS)	The interval from the date of randomization until the first date on distant metastasis, death due to any cause, or second primary invasive breast cancer	10 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): November 27, 2025
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: safety; adjuvant treatment; moxifloxacin; operable breast cancer; disease-free survival
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin; Cyclophosphamide
• Other Study ID Numbers: SYSUCC-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We decided to not share our individual participant data (IPD) to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No