Breast Cancer
Conditions
Keywords
moxifloxacin, operable breast cancer, adjuvant treatment, disease-free survival, safety
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.
Interventions
DRUGstandard 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 Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days
DRUGstandard 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 Placebo 0.4 PO once daily days 1-5; cycled every 21 days
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 10 years | The interval from the date of randomization until the first date on death due to any cause, or the last follow-up time |
| distant disease-free survival (DDFS) | 10 years | 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 |
Countries
China
Outcome results
None listed