Actively Recruiting
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
Led by Sun Yat-Sen University Cancer Center · Updated on 2025-12-17
228
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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), HER2 negative (IHC 0-1 or FISH negative)
- No prior therapy after first recurrence or metastatic diagnosis
- At least 1 measurable lesion per RECIST criteria
- Neutrophil-to-lymphocyte ratio in peripheral blood ≥ 2
- Adequate organ function including bone marrow, kidneys, liver, and heart (LVEF ≥45%)
- Compliance with study protocol
- Provided written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Definitive BRCA mutation, PD-L1 positive, MSI-high, or mismatch repair deficient
- Receiving or planning to receive other biological agents or immunotherapy
- Uncontrolled medical problems
- Evidence of active acute or chronic infection
- Hepatic, renal, cardiac, or bone marrow dysfunction as specified
- Concurrent or recent (within 5 years) other malignancy
- Known severe hypersensitivity to moxifloxacin
- Unable or unwilling to comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhong-yu Yuan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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