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NCT Number: NCT05114720

Moxifloxacin in Adjuvant Treatment of Patients With 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus antibiotic (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

Other names: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo

Primary outcomes

  1. disease-free survival (DFS)

    Time frame: 10 years

    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

Secondary outcomes

  1. overall survival (OS)

    Time frame: 10 years

    The interval from the date of randomization until the first date on death due to any cause, or the last follow-up time

  2. distant disease-free survival (DDFS)

    Time frame: 10 years

    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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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