NCT04722978 Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
| NCT ID | NCT04722978 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-Sen University Cancer Center |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2021-04-20 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 228 participants in total. It began in 2021-04-20 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Zhong-yu Yuan, M.D.
STUDY CHAIR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT04722978 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04722978 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 228 participants.
Is NCT04722978 currently recruiting?
Yes, NCT04722978 is actively recruiting participants. Contact the research team at yuanzhy@sysucc.org.cn for enrollment information.
Where is the NCT04722978 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04722978 clinical trial?
NCT04722978 is sponsored by Sun Yat-Sen University Cancer Center. The principal investigator is Zhong-yu Yuan, M.D. at Sun Yat-sen University. The trial plans to enroll 228 participants.
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