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

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.

Eligibility

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.

Conditions3

Browse More Trials