NCT07104266 Triple Negative Breast Cancer and Celecoxib. Pilot Study
| NCT ID | NCT07104266 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Université de Sherbrooke |
| Condition | Triple-Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2028-08-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-08-04 with a primary completion date of 2028-08-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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-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.
Eligibility Criteria
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
Contact & Investigator
Benoit Paquette, Ph.D.
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT07104266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple-Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07104266 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07104266 currently recruiting?
Yes, NCT07104266 is actively recruiting participants. Contact the research team at benoit.paquette@usherbrooke.ca for enrollment information.
Where is the NCT07104266 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT07104266 clinical trial?
NCT07104266 is sponsored by Université de Sherbrooke. The principal investigator is Benoit Paquette, Ph.D. at Université de Sherbrooke. The trial plans to enroll 30 participants.
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