Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Sun Yat-sen University559 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

559

Conditions

Breast Cancer

Interventions

standard adjuvant chemotherapy plus moxifloxacinDRUG

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 placeboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have provided written and signed informed consent; 2. Histologically confirmed invasive ductal carcinoma; 3. Planned to received (neo)/adjuvant chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; 5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 6. 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. 7. Compliance with the study protocol. Exclusion Criteria: 1. Pregnant or breast feeding; 2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2; 3. Hypersensitivity to moxifloxacin or quinolones compounds; 4. Concomitant with other antitumor therapies or participating in other clinical trials; 5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease; 6. Severe uncontrolled co-infection, or severe metabolic disorders; 7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 8. Poor compliance, unwillingness or inability to follow protocol to continue the study; 9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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