Using moxifloxacin with chemotherapy for operable breast cancer

A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer

This study is testing if adding the antibiotic moxifloxacin to standard chemotherapy helps people with operable breast cancer live longer without their disease coming back.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05114720 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial aims to compare the disease-free survival of patients with operable breast cancer who are treated with standard adjuvant chemotherapy combined with moxifloxacin versus those receiving a placebo. It is a multicenter, randomized, double-blind, placebo-controlled study designed to assess both the efficacy and safety of this combination treatment. The trial plans to enroll up to 520 subjects to gather robust data on the potential benefits of adding moxifloxacin to standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are women with histologically confirmed invasive ductal carcinoma who are planned to receive (neo)adjuvant chemotherapy and have an ECOG score of 0 to 1.

Not a fit: Patients who are pregnant, breastfeeding, or have an ECOG score of 2 or higher may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival rates for patients with operable breast cancer.

How similar studies have performed: Other studies have explored the use of antibiotics in cancer treatment, but the specific combination of moxifloxacin with chemotherapy in this context is relatively novel.

Eligibility 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Zhongyu Yuan, Professor

Conditions: Breast Cancer, moxifloxacin, operable breast cancer, adjuvant treatment, disease-free survival, safety