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โ† Trials
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Triple Negative Breast Cancer and Celecoxib. Pilot Study

RecruitingPhase 2Ages 18 Years - anyFemaleUniversitรฉ de Sherbrooke
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female * Age: 18 years or older * Tumor stage: Early * TNBC status confirmed by pathology * Regional lymph node N0 to N3 * No evidence of distant metastasis * Primary tumor removed by conservative surgery with negative margins Exclusion Criteria: Participants will be excluded if they have experienced any of the following conditions in the last six months: * Stomach ulcer * Kidney disease: Glomerular filtration rate lower than 50 mL/min * Liver disease: Aspartate aminotransferase / Alanine aminotransferase - 3 times the upper limit of normal, Bilirubine - 2 times the upper limit of normal, INR - 1.3 times the upper limit of normal, Cirrhose Child-Pugh B or more * Congestive heart failure: Left ventricular ejection fraction lower than 50% * Participants taking an NSAID for another medical condition or as needed before starting their radiotherapy treatment. Participants who have demonstrated: * Hypersensitivity to celecoxib * A history of allergic reactions to sulfonamides * A history of asthma attacks, urticaria, or allergic reactions after taking acetylsalicylic acid or another nonsteroidal anti-inflammatory drug * The presence of inflammatory bowel disease * Proven hyperkalemia
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What it tests

  • Celecoxib (Celebrex)
  • Placebo
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Where

1 site
Faculty of medicine and health sciences
Sherbrooke, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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