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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talniflumate

Drug

Talniflumate was administered

Primary outcomes

Disease free survival (DFS)

Time frame: 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 outcomes

Overall survival (OS)

Time frame: Up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qifeng Yang, Professor

CONTACT

[email protected]

+8618560085168

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Jan 16, 2025
Registry last updated: Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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