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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhong-yu Yuan, M.D.
• Email: yuanzhy@sysucc.org.cn
• Phone: 862087342794

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.