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

Inclusion Criteria7

  • 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 Criteria12

  • 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

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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