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

Triple Negative Breast Cancer Clinical Trial

Official title:

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722978
• Other study ID #: SYSUCC-003
• Status: Recruiting
• Phase: Phase 3
• Start date: April 20, 2021
• Est. completion date: February 2025

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Zhong-yu Yuan, M.D.
• Phone: 862087342794
• Email: yuanzhy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
• Gemcitabine combined with carboplatin plus placebo
Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	The interval from the date of randomization until the first date on which progression, or death due to any cause	36 months