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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

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

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

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 Placebo 0.4 PO once daily days 1-5; cycled every 21 days

standard adjuvant chemotherapy plus placebo

Zhongyu Yuan, Professor

Yuanyi Zhong, MD

Zhong-Yu Yuan, M.D.

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.

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.

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

We decided to not share our individual participant data (IPD) to other researchers.

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

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

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

Sun Yat-sen University

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer	NCT05114720	Breast Cancer	standard adjuva... standard adjuva...	18 Years - 70 Years	Sun Yat-sen University
Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer	NCT05114720	Breast Cancer	standard adjuva... standard adjuva...	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for standard adjuvant chemotherapy plus moxifloxacin