Triple-Negative Breast CancerPhase 2NCT07104266
Triple Negative Breast Cancer and Celecoxib. Pilot Study
A Phase 2 study testing Celecoxib (Celebrex) in people with Triple-Negative Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- Celecoxib (Celebrex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2025to 4 Aug 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Faculty of medicine and health sciences
Sherbrooke, Quebec, J1H 5N4
Benoit Paquette, Ph.D., 819-821-8000 ext. 74767, benoit.paquette@usherbrooke.ca
Hélène Therriault, M.Sc., 819-821-8000 ext. 73060, Helene.Therriault@USherbrooke.ca
About this study
Official title: Determine Whether Administering Celecoxib During Radiotherapy Can Reduce the Risk of Recurrence of Triple-negative Breast Cancer. Pilot Study
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.
Read the detailed description
Adults with non-metastatic TNBC will be recruited. The overall aim is to determine whether administering celecoxib during RT could reduce the risk of cancer recurrence. The hypothesis is that celecoxib will block the increase in cytokines, induced by RT, that are known to promote cancer cell invasion and metastasis. 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.
Thirty participants will be recruited and randomized: fifteen will receive celecoxib, and fifteen will receive a placebo. Participants who take a COX-2 inhibitor for other medical indications or medications such as ibuprofen will be excluded.
Participants are recruited after chemotherapy and removal of the tumor by partial mastectomy. They take one capsule celecoxib (100 mg) or placebo after breakfast and one after supper, starting 7 days before RT and ending 14 days after RT. RT will consist of 26 Gy in 5 fractions or 40 Gy in 15 fractions if participants are under 50 years old with lymph node positivity. According to the RT plan, celecoxib will be taken for no longer than 40 days. In a logbook, participants will report when they take celecoxib and if they experience discomfort, such as skin rashes, headaches, or dizziness. Participant follow-up will last 5 years after treatment, according to clinical guidelines, which include a clinical examination and a mammogram every year. If breast density is categorized as D (extremely dense), an MRI will be performed in alternating years with the mammogram. A CT or PET scan will be conducted if symptoms such as bone pain are present. The date corresponding to the detection of a local or distant recurrence will be recorded in the participant's file to determine whether taking celecoxib could reduce the risk of regional or distant recurrence.
The secondary objective is to determine whether taking celecoxib will prevent the increase in cytokines induced by RT, some of which are known to stimulate the invasion capacity of cancer cells and the formation of metastases. This will be determined by collecting plasma samples at four time points: 1) the day before the start of taking celecoxib or placebo, which corresponds to 7 days before starting RT, 2) the day of the start of RT and just before administering the 1st fraction of radiation, 3) after the 4th fraction of radiation, and 4) 14 days after the end of RT and stopping taking celecoxib or placebo. During the blood draw, participants will be questioned by the research nurse to ensure that celecoxib is well tolerated. The impact of celecoxib on changes in cytokines will be determined using laser bead multiplexing.
- Conditions
- Triple-Negative Breast Cancer
- Being tested
- Celecoxib (Celebrex), Placebo
- Keywords
- Triple-Negative Breast Cancer, cytokines, Celecoxib
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib (Celebrex)Drug
Also called Chemotherapy, radiotherapy
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.
PlaceboDrug
Also called Chemotherapy, radiotherapy
Participants will take one capsule of placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One capsule placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy. Receives: 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. Receives: Drug: Celecoxib (Celebrex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Secondary outcomes (1)
Determine the ability of celecoxib to prevent the stimulation of cytokine levels induced by radiotherapy.
The secondary objective is to evaluate the ability of celecoxib to inhibit the radiotherapy-induced elevation of cytokines associated with cancer cell invasion and metastasis development. This will be determined by quantifying and comparing the level of cytokines in plasma samples collected from 30 participants at 4 times: 1) The day before the start of taking celecoxib or placebo, which corresponds to 7 days before starting radiotherapy, 2) the day of the start of radiotherapy and just before administering the 1st fraction of radiation, 3) after the 4th fraction of radiation, and 4) 14 days after the end of radiotherapy and stopping taking celecoxib or placebo.
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start4 Aug 2025 (estimated)
- Primary completion4 Aug 2028 (estimated)
- Study completion4 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Paquette, Université de Sherbrooke
- Investigators
- Benoit Paquette, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104266
- Sponsor's protocol ID
- TNBC2025-5681
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, tumor diameter, stage, chemotherapy and radiotherapy plans, Ki-67 status, administration of pembrolizumab, quantification of cytokine levels in plasma, and relapse 5-years post-treatment
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine Whether Administering Celecoxib During Radiotherapy Can Reduce the Risk of Recurrence of Triple-negative Breast Cancer. Pilot Study
- ClinicalTrials.gov ID
- NCT07104266
- Acronym / sponsor ID
- TNBC2025-5681
- Conditions
- Triple-Negative Breast Cancer
- Keywords
- Triple-Negative Breast Cancer, cytokines, Celecoxib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 4 Aug 2025 (estimated)
- Primary completion
- 4 Aug 2028 (estimated)
- Study completion
- 4 Aug 2032 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adults with non-metastatic TNBC will be recruited. The overall aim is to determine whether administering celecoxib during RT could reduce the risk of cancer recurrence. The hypothesis is that celecoxib will block the increase in cytokines, induced by RT, that are known to promote cancer cell invasion and metastasis. 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.
Thirty participants will be recruited and randomized: fifteen will receive celecoxib, and fifteen will receive a placebo. Participants who take a COX-2 inhibitor for other medical indications or medications such as ibuprofen will be excluded.
Participants are recruited after chemotherapy and removal of the tumor by partial mastectomy. They take one capsule celecoxib (100 mg) or placebo after breakfast and one after supper, starting 7 days before RT and ending 14 days after RT. RT will consist of 26 Gy in 5 fractions or 40 Gy in 15 fractions if participants are under 50 years old with lymph node positivity. According to the RT plan, celecoxib will be taken for no longer than 40 days. In a logbook, participants will report when they take celecoxib and if they experience discomfort, such as skin rashes, headaches, or dizziness. Participant follow-up will last 5 years after treatment, according to clinical guidelines, which include a clinical examination and a mammogram every year. If breast density is categorized as D (extremely dense), an MRI will be performed in alternating years with the mammogram. A CT or PET scan will be conducted if symptoms such as bone pain are present. The date corresponding to the detection of a local or distant recurrence will be recorded in the participant's file to determine whether taking celecoxib could reduce the risk of regional or distant recurrence.
The secondary objective is to determine whether taking celecoxib will prevent the increase in cytokines induced by RT, some of which are known to stimulate the invasion capacity of cancer cells and the formation of metastases. This will be determined by collecting plasma samples at four time points: 1) the day before the start of taking celecoxib or placebo, which corresponds to 7 days before starting RT, 2) the day of the start of RT and just before administering the 1st fraction of radiation, 3) after the 4th fraction of radiation, and 4) 14 days after the end of RT and stopping taking celecoxib or placebo. During the blood draw, participants will be questioned by the research nurse to ensure that celecoxib is well tolerated. The impact of celecoxib on changes in cytokines will be determined using laser bead multiplexing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne capsule placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy. |
| Celecoxib (celebrex) | Experimental | Drug: Celecoxib (Celebrex)One capsule celecoxib (100 mg) after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age: 18 years or older
- Tumor stage: Early
- TNBC status confirmed by pathology
- Regional lymph node N0 to N3
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib (Celebrex)Also: Chemotherapy, radiotherapyThe 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 | Celecoxib (celebrex) |
| PlaceboAlso: Chemotherapy, radiotherapyParticipants will take one capsule of placebo after breakfast and one after supper, starting 7 days before radiotherapy and ending 14 days after radiotherapy. | Drug | Placebo |
Primary outcome
Number of participants needed to assess the reduction in recurrence rate by administering celecoxid during radiotherapy
Time frame: Up to 36 months
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.
1 secondary outcome
Determine the ability of celecoxib to prevent the stimulation of cytokine levels induced by radiotherapy.
Time frame: Up to 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. Age, tumor diameter, stage, chemotherapy and radiotherapy plans, Ki-67 status, administration of pembrolizumab, quantification of cytokine levels in plasma, and relapse 5-years post-treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoit Paquette, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib (Celebrex) in people with Triple-Negative Breast Cancer, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit Paquette, Ph.D. (1-819-821-8000 ext. 74767, benoit.paquette@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.