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

NCT06777537 | Not Yet Recruiting Phase 4

• 1 other identifier: HECT005
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Secondary Outcomes (1)

• Overall survival (OS)

  Up to 5 years

Study Arms (2)

Talniflumate

EXPERIMENTAL

Patients will be treated with adjuvant treatment . And Talniflumate will be administrated.

Drug: Talniflumate

Placebo

NO INTERVENTION

Patients will be treated with Placebo

Interventions

Talniflumate DRUG

Talniflumate was administered

Talniflumate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Related Publications (4)

• Wang X, Chen B, Zhang H, Peng L, Liu X, Zhang Q, Wang X, Peng S, Wang K, Liao L. Integrative analysis identifies molecular features of fibroblast and the significance of fibrosis on neoadjuvant chemotherapy response in breast cancer. Int J Surg. 2024 Jul 1;110(7):4083-4095. doi: 10.1097/JS9.0000000000001360.

  PMID: 38546506 BACKGROUND

• Spanheimer PM, Reeder-Hayes KE. Breast surgery after neoadjuvant chemotherapy: time for a change? Lancet Oncol. 2022 Dec;23(12):1477-1479. doi: 10.1016/S1470-2045(22)00649-0. Epub 2022 Oct 25. No abstract available.

  PMID: 36306811 BACKGROUND

• Rao CV, Janakiram NB, Madka V, Kumar G, Scott EJ, Pathuri G, Bryant T, Kutche H, Zhang Y, Biddick L, Gali H, Zhao YD, Lightfoot S, Mohammed A. Small-Molecule Inhibition of GCNT3 Disrupts Mucin Biosynthesis and Malignant Cellular Behaviors in Pancreatic Cancer. Cancer Res. 2016 Apr 1;76(7):1965-74. doi: 10.1158/0008-5472.CAN-15-2820. Epub 2016 Feb 15.

  PMID: 26880801 BACKGROUND

• Agostini A, Guerriero I, Piro G, Quero G, Roberto L, Esposito A, Caggiano A, Priori L, Scaglione G, De Sanctis F, Sistigu A, Musella M, Larghi A, Rizzatti G, Lucchetti D, Alfieri S, Sgambato A, Bria E, Bizzozero L, Arena S, Ugel S, Corbo V, Tortora G, Carbone C. Talniflumate abrogates mucin immune suppressive barrier improving efficacy of gemcitabine and nab-paclitaxel treatment in pancreatic cancer. J Transl Med. 2023 Nov 23;21(1):843. doi: 10.1186/s12967-023-04733-z.

  PMID: 37996891 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

talniflumate

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qifeng Yang, Professor

CONTACT

+8618560085168; qifengy_sdu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 16, 2025

Record last verified: 2025-01