Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Anti-Bacterial Agents; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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.