Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gemcitabine and carboplatin plus antibiotic (moxifloxacin), Gemcitabine combined with carboplatin plus placebo.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin) - Drug Gemcitabine combined with carboplatin plus placebo
Standard chemotherapy (gemcitabine and carboplatin) plus placebo
Primary outcome measures
- progression-free survival (PFS) [Time frame: 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT04722978 · SYSUCC-003