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

Launched by SUN YAT-SEN UNIVERSITY · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of adding a medication called moxifloxacin to standard chemotherapy for women with advanced triple-negative breast cancer, a type of breast cancer that does not respond to certain hormonal therapies. The main goal is to see if this combination can help patients live longer without their cancer getting worse compared to those who receive standard chemotherapy alone.

To qualify for the trial, participants must be women aged 18 to 100 with a specific type of breast cancer that has spread and must not have had any previous treatments for this advanced stage. They also need to have certain health criteria, including good organ function and no significant infections or other cancers. If someone joins the study, they can expect to receive regular treatments and follow-up appointments to monitor their health and the effects of the medication. This trial is currently recruiting participants, so there is an opportunity for eligible patients to contribute to important research in this area.

Gender

FEMALE

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.