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

Phase 3

Recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin); Drug: Gemcitabine combined with carboplatin plus placebo

• Registration Number: NCT04722978
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer. This study is designed to recruit up to 228 subjects.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Study Start: 2021-04-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Gemcitabine and carboplatin plus antibiotic (moxifloxacin)	Gemcitabine combined with carboplatin plus moxifloxacin
Control group	Gemcitabine combined with carboplatin plus placebo	Gemcitabine combined with carboplatin plus placebo

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	36 months	The interval from the date of randomization until the first date on which progression, or death due to any cause

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China