Recruiting
Phase 2

Celecoxib with RT

Sponsor:

Université de Sherbrooke

Code:

NCT07104266

Conditions

Triple-Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Celecoxib (Celebrex)

Placebo

Study Details

Brief 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.

Conditions

Triple-Negative Breast Cancer

Study ID

NCT07104266

Start date

Aug 4, 2025

Status verified date

Jul, 2025

Completion date

Aug 4, 2032

Anticipated

Primary completion date

Aug 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

One capsule placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy.

experimental: Celecoxib (celebrex)

One capsule celecoxib (100 mg) after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy.

Interventions

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.

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.

Primary outcome measure

  • Number of participants needed to assess the reduction in recurrence rate by administering celecoxid during radiotherapy [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Locations

Faculty of medicine and health sciences

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Principal Investigator:

Benoit Paquette, Ph.D.

More Information

Sponsor

Université de Sherbrooke

Last update posted

Aug 5, 2025

Last verified

Jul, 2025

Keywords

  • Triple-Negative Breast Cancer
  • cytokines
  • Celecoxib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-08-05.