Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: standard adjuvant chemotherapy plus moxifloxacin
* Drug: standard adjuvant chemotherapy plus placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard adjuvant chemotherapy plus moxifloxacin<br>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<br>* 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<br>* 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<br>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<br>* 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<br>* Other names: Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxifloxacin, operable breast cancer, adjuvant treatment, disease-free survival, safety