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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04722978

Collaborator

(none)

228

Enrollment

Location

Arms

45.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin) Drug: Gemcitabine combined with carboplatin plus placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Gemcitabine combined with carboplatin plus moxifloxacin or placeboGemcitabine combined with carboplatin plus moxifloxacin or placebo

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental group Gemcitabine combined with carboplatin plus moxifloxacin	Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin) Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin) Other Names: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days
Placebo Comparator: Control group Gemcitabine combined with carboplatin plus placebo	Drug: Gemcitabine combined with carboplatin plus placebo Standard chemotherapy (gemcitabine and carboplatin) plus placebo Other Names: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Arm

Intervention/Treatment

Active Comparator: Experimental group

Gemcitabine combined with carboplatin plus moxifloxacin

Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)

Other Names:

Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days

Placebo Comparator: Control group

Gemcitabine combined with carboplatin plus placebo

Drug: Gemcitabine combined with carboplatin plus placebo

Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Other Names:

Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.