Celecoxib during radiotherapy for early triple-negative breast cancer
Determine Whether Administering Celecoxib During Radiotherapy Can Reduce the Risk of Recurrence of Triple-negative Breast Cancer. Pilot Study
This test gives celecoxib pills during radiotherapy to see if it can stop radiation-triggered cytokine increases and lower the chance of recurrence in adults with early-stage triple-negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Université de Sherbrooke Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT07104266 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled pilot phase 2 trial that will enroll 30 adults with non-metastatic, early-stage triple-negative breast cancer after breast-conserving surgery and chemotherapy. Participants will be randomized 1:1 to receive celecoxib 100 mg twice daily or placebo starting 7 days before radiotherapy and continuing until 14 days after radiotherapy (up to 40 days total), with radiotherapy delivered as 26 Gy in 5 fractions or 40 Gy in 15 fractions depending on nodal status and age. The primary objective is to test feasibility of recruitment and study procedures for a future larger trial; the key secondary objective is to see if celecoxib prevents radiotherapy-induced increases in cytokines linked to metastasis. Participants will be followed clinically for 5 years with periodic exams and mammography per guidelines.
Who should consider this trial
Good fit: Adult women with early-stage, non-metastatic triple-negative breast cancer who have had breast-conserving surgery and chemotherapy and who are eligible for radiotherapy and can safely take celecoxib are ideal candidates.
Not a fit: Patients with distant metastasis, recent or ongoing use of NSAIDs or COX-2 inhibitors, active peptic ulcer, significant kidney or liver disease, reduced heart function, known hypersensitivity to celecoxib, or who cannot attend the Sherbrooke site are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, adding celecoxib during radiotherapy could reduce inflammation-driven metastasis and lower the risk of cancer recurrence.
How similar studies have performed: Preclinical work and some clinical studies suggest COX-2 inhibitors can lower inflammatory cytokines, but clinical results on cancer outcomes have been mixed and the specific approach of using celecoxib during radiotherapy for TNBC is largely untested in large trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sherbrooke, Quebec
- Faculty of medicine and health sciences — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Benoit Paquette, Ph.D. — Université de Sherbrooke
- Study coordinator: Benoit Paquette, Ph.D.
- Email: benoit.paquette@usherbrooke.ca
- Phone: 1-819-821-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.