Breast Cancer Clinical Trial
Official title:
A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
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.
Status | Recruiting |
Enrollment | 520 |
Est. completion date | December 2028 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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