Overview

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.