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Triple Negative Breast Cancer and Celecoxib. Pilot Study

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Relapses occur in 20 to 30% of patients with early-stage triple-negative breast cancer (TNBC), which is characterized by the absence of three receptors: the estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2). Radiotherapy (RT) can increase or decrease, depending on the patient, the level of cytokines that promote metastasis development. To help prevent the development of metastasis, the cyclooxygenase-2 (COX-2) inhibitor celecoxib will be administered during RT. This treatment aims to prevent RT-induced cytokine increases and, ultimately, improve patient prognosis. The primary objective of this pilot study is to assess the feasibility of recruiting participants and implementing the study steps, with the intention of conducting a large-scale study in the future. The secondary objective is to evaluate celecoxib ability to inhibit the RT-induced stimulation of cytokines associated with metastasis development. This will be assessed by comparing the levels of these cytokines in plasma samples collected before, during, and after RT. In the exploratory objective, TNBC cells will be incubated in vitro with these plasma samples to determine whether administering celecoxib during RT can prevent increased cancer cell invasion and metastasis formation in mice.
Trial Details
NCT Number NCT07104266
Lead Sponsor Université de Sherbrooke
Conditions
(from sponsor)
Triple-Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov