Neoadjuvant Chemotherapy with or Without Talniflumate for the Treatment of Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Talniflumate.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Talniflumate
Talniflumate was administered
Primary outcome measures
- Disease free survival (DFS) [Time frame: Up to 5 years]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: Up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
- 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 canc PMID 37996891
Identifiers
NCT: NCT06777537 · HECT005