About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 18 and ≤ 75 years, female;
The breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
Not receiving any preoperative anticancer drugs;
The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) < 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 1.5 ULN;
Disqualifiers
Patients with stage IV breast cancer;
Pregnant or lactating women;
Those with active bleeding due to various reasons;
Those with HIV infection or AIDS-associated diseases;
Trial design
Parallel
Treatments tested in this trial
Talniflumate
DrugTalniflumate was administered
Treatment groups
Trial outcomes
Primary outcomes
Disease free survival (DFS)
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 5 years.
Secondary outcomes
Overall survival (OS)
Time from randomization to death from any cause, assessed up to 5 years.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: