Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Anti-Bacterial Agents; Carboplatin; Gemcitabine; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.