A Phase 3 interventional study of standard adjuvant chemotherapy plus moxifloxacin and standard adjuvant chemotherapy plus placebo in Breast Cancer, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 559 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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 (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 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)
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
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
Time frame: 10 years
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
Time frame: 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
Time frame: 10 years
Plan to share: No — We decided to not share our individual participant data (IPD) to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University