Celecoxib during radiotherapy for early triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.