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

NCT ID: NCT06777537

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2030-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Talniflumate

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

Group Type: EXPERIMENTAL

Talniflumate

Intervention Type: DRUG

Talniflumate was administered

Placebo

Patients will be treated with Placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Talniflumate

Talniflumate was administered

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qifeng Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qifeng Yang, Professor

Role: CONTACT

qifengy_sdu@163.com

+8618560085168

References

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.

Reference Type: BACKGROUND

PMID: 38546506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36306811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26880801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37996891 (View on PubMed)

Other Identifiers

HECT005

Identifier Type: -

Identifier Source: org_study_id