A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- standard adjuvant chemotherapy plus moxifloxacin
- Conditions
- Breast Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 559
- Locations
- 1
- Primary Endpoint
- disease-free survival (DFS)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Detailed Description
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.
Investigators
Zhong-yu Yuan
Professor of Medicine
Sun Yat-sen University
Eligibility Criteria
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.
Arms & Interventions
standard adjuvant chemotherapy plus moxifloxacin
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
Intervention: standard adjuvant chemotherapy plus moxifloxacin
standard adjuvant chemotherapy plus placebo
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
Intervention: standard adjuvant chemotherapy plus placebo
Outcomes
Primary Outcomes
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
- distant disease-free survival (DDFS)(10 years)
- overall survival (OS)(10 years)