Triple Negative Breast Cancer
Conditions
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.
Interventions
DRUGGemcitabine and carboplatin plus antibiotic (moxifloxacin)
Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
DRUGGemcitabine combined with carboplatin plus placebo
Standard chemotherapy (gemcitabine and carboplatin) plus placebo
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Gemcitabine combined with carboplatin plus moxifloxacin or placebo
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZhong-yu Yuan, M.D.
Outcome results
None listed