Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

NCT05114720 | Completed Phase 3

• 1 other identifier: SYSUCC-015
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

moxifloxacin; operable breast cancer; adjuvant treatment; disease-free survival; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• overall survival (OS)

  10 years

• distant disease-free survival (DDFS)

  10 years

Study Arms (2)

standard adjuvant chemotherapy plus moxifloxacin

EXPERIMENTAL

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

standard adjuvant chemotherapy plus placebo

PLACEBO COMPARATOR

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

Interventions

standard adjuvant chemotherapy plus moxifloxacin DRUG

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

Also known as: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus antibiotic (moxifloxacin)

standard adjuvant chemotherapy plus moxifloxacin

standard adjuvant chemotherapy plus placebo DRUG

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

Also known as: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo

standard adjuvant chemotherapy plus placebo

Eligibility Criteria

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

You may qualify if:

• Have provided written and signed informed consent;
• Histologically confirmed invasive ductal carcinoma;
• Planned to received (neo)/adjuvant chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
• Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
• 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.
• Compliance with the study protocol.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Moxifloxacin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

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: Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 10, 2021
• Study Start: November 11, 2021
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)