Combining standard chemotherapy with moxifloxacin for treating metastatic triple-negative breast cancer

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial

This study is testing if adding moxifloxacin to standard chemotherapy can help people with metastatic triple-negative breast cancer live longer without their cancer getting worse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04722978 on ClinicalTrials.gov

What this trial studies

This phase 3 trial aims to evaluate the effectiveness and safety of standard chemotherapy combined with moxifloxacin compared to a placebo in patients with metastatic triple-negative breast cancer. The study is multicenter, randomized, and double-blind, involving up to 228 participants. The primary focus is on measuring progression-free survival (PFS) among the different treatment groups. Eligible patients must have specific cancer characteristics and meet certain health criteria.

Who should consider this trial

Good fit: Ideal candidates are patients with metastatic triple-negative breast cancer who have not received prior therapy after diagnosis.

Not a fit: Patients who are pregnant, breastfeeding, or have certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve progression-free survival for patients with metastatic triple-negative breast cancer.

How similar studies have performed: Other studies have explored similar combinations of chemotherapy and antibiotics, but this specific approach is novel in the context of metastatic triple-negative breast cancer.

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
* Histologically confirmed invasive ductal carcinoma, no specific type (NOS)
* ER negative and progesterone receptor (PR) negative (defined as \< 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).
* No prior therapy after first recurrence or diagnosis of metastatic disease.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).
* Compliance with the study protocol.
* Have provided written and signed informed consent.

Exclusion Criteria:

* Pregnant or breast feeding.
* Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).
* Patients who are receiving or will receive other biological agents or immunotherapy.
* Uncontrolled medical problems.
* Evidence of active acute or chronic infection.
* Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.
* Concurrent malignancy or history of other malignancy within the last five years.
* Known severe hypersensitivity to moxifloxacin
* Patients were unable or unwilling to comply with program requirements.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Zhong-yu Yuan, M.D.

Conditions Triple Negative Breast Cancer