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

Last updated: January 14, 2025
Sponsor: Shandong University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

Talniflumate

Clinical Study ID

NCT06777537
HECT005
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: ≥ 18 and ≤ 75 years, female;

  • The breast cancer has been confirmed by pathological examination andImmunohistochemistry (IHC);

  • Not receiving any preoperative anticancer drugs;

  • The liver and kidney function satisfies the following conditions within 3 days aftersurgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetictransaminase (ALT) < 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serumcreatinine < 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

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 withstudy compliance;

  • Conditions that are considered not suitable for this study investigators

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Talniflumate
Phase: 4
Study Start date:
June 01, 2025
Estimated Completion Date:
December 01, 2030