Triple Negative Breast Cancer and Celecoxib. Pilot Study

NCT07104266 | Recruiting Phase 2

• 1 other identifier: TNBC2025-5681
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Triple-Negative Breast Cancer; cytokines; Celecoxib

Outcome Measures

Primary Outcomes (1)

• Number of participants needed to assess the reduction in recurrence rate by administering celecoxid during radiotherapy

  This pilot study aims to assess the feasibility of recruiting participants to take celecoxib during radiotherapy and to estimate the sample size required to obtain statistically significant results (p-value ≤ 0.05), which will be the subject of a subsequent larger-scale study. A reduction of 20% of recurrence rate 3 years post-radiotherapy will be used to estimate the sample size.

  Up to 36 months

Secondary Outcomes (1)

• Determine the ability of celecoxib to prevent the stimulation of cytokine levels induced by radiotherapy.

  Up to 45 days

Other Outcomes (1)

• Ability of celecoxib to prevent radiotherapy-stimulation of cancer cell invasion

  Up to 45 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Celecoxib (celebrex)

EXPERIMENTAL

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

Drug: Celecoxib (Celebrex)

Interventions

Celecoxib (Celebrex) DRUG

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.

Also known as: Chemotherapy, radiotherapy

Celecoxib (celebrex)

Placebo DRUG

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

Also known as: Chemotherapy, radiotherapy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Faculty of medicine and health sciences

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Celecoxib; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Benoit Paquette, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit Paquette, Ph.D.

CONTACT

1-819-821-8000; benoit.paquette@usherbrooke.ca

Hélène Therriault, M.Sc.

CONTACT

1-819-821-8000; Helene.Therriault@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 5, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 4, 2028
• Study Completion (Estimated): August 4, 2032
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: August 2025 to August 2032
• Access Criteria: Clinicians and basic researchers may request study data from the principal investigator. Participants' clinical data, such as age and disease stage, as well as data collected during the study, will be made available.

Locations

CA (1)