Triple Negative Breast Cancer and Celecoxib. Pilot Study
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 t
| Condition(s) | Triple-Negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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-sc |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Université de Sherbrooke |
| Locations | Sherbrooke, Quebec, Canada |
| Start date | 2025-08-04 |
| NCT ID | NCT07104266 |
| Official listing | https://clinicaltrials.gov/study/NCT07104266 |