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

Phase 4

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Talniflumate

• Registration Number: NCT06777537
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Study Start: 2025-06-01
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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;
• Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count > 1.5×109/L;
• The expected survival time ≥ 6 months;
• The subjects volunteer to sign the informed consent.

Exclusion Criteria

• 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;
• Those with severe acute and chronic diseases;
• Those with severe diabetes;
• Those with serious infectious diseases;
• Those who can not take drugs by oral route;
• Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
• Conditions that are considered not suitable for this study investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talniflumate	Talniflumate	Patients will be treated with adjuvant treatment . And Talniflumate will be administrated.

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	Up to 5 years	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 Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 5 years	Time from randomization to death from any cause, assessed up to 5 years.