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RECRUITING
NCT07104266
PHASE2

Triple Negative Breast Cancer and Celecoxib. Pilot Study

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-08-04

Completion Date

2032-08-04

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

DRUG

Celecoxib (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.

DRUG

Placebo

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