NCT06777537

Neoadjuvant Chemotherapy with or Without Talniflumate for the Treatment of Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Talniflumate, a prodrug of niflumic acid with significant anti-inflammatory properties, has emerged as a promising candidate in breast cancer therapy due to its ability to modulate key oncogenic pathways. Its mechanisms of action include the inhibition of cyclooxygenase (COX) enzymes, which mitigates tumor-promoting inflammation and fosters a less permissive microenvironment for cancer progression. Additionally, talniflumate disrupts ionic homeostasis by targeting calcium-activated chloride channels (CaCCs), leading to impaired cellular proliferation and potential induction of apoptosis. The agent also exhibits anti-angiogenic activity by downregulating vascular endothelial growth factor (VEGF), thereby restricting tumor vascularization and growth. Furthermore, talniflumate shows potential as a chemosensitizer, enhancing the cytotoxic effects of standard chemotherapy and improving therapeutic outcomes while reducing chemoresistance. These multifaceted mechanisms highlight the therapeutic promise of talniflumate in breast cancer, warranting further preclinical and clinical studies to validate its efficacy, refine dosing strategies, and define its role in combination therapies. PURPOSE: To assess the therapeutic efficacy of Talniflumate in the management of breast cancer, with a focus on its synergistic interactions with neoadjuvant chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Talniflumate	Talniflumate was administered

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-01-16
• Last updated: 2025-01-16