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

Phase 4Not Yet RecruitingNCT06777537

Shandong University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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.

Time frame: Up to 5 years

Secondary Outcomes

Overall survival (OS)

Time from randomization to death from any cause, assessed up to 5 years.