RecruitingPhase 2NCT07104266

Triple Negative Breast Cancer and Celecoxib. Pilot Study

Determine Whether Administering Celecoxib During Radiotherapy Can Reduce the Risk of Recurrence of Triple-negative Breast Cancer. Pilot Study


Sponsor

Université de Sherbrooke

Enrollment

30 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is exploring whether adding celecoxib — an anti-inflammatory painkiller — to standard treatment after surgery can help women with early-stage triple negative breast cancer (an aggressive type that lacks common hormone receptors). **You may be eligible if...** - You are a woman aged 18 or older - You have early-stage triple negative breast cancer (TNBC) confirmed by pathology - You have had breast-conserving surgery with clear margins - Your cancer has not spread to distant organs **You may NOT be eligible if...** - You have had a stomach ulcer, significant kidney disease (GFR below 50), liver disease, heart failure, or blood clotting problems in the last 6 months - You are currently taking NSAIDs (like ibuprofen or naproxen) or blood thinners - You have an allergy to celecoxib or similar medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCelecoxib (Celebrex)

The participants will take one capsule celecoxib (100 mg) or placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy.

DRUGPlacebo

Participants will take one capsule of placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy.


Locations(1)

Faculty of medicine and health sciences

Sherbrooke, Quebec, Canada

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NCT07104266


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