RecruitingPHASE2INTERVENTIONAL

Triple Negative Breast Cancer and Celecoxib. Pilot Study

This study is for women with an early form of triple-negative breast cancer (TNBC) who have had surgery and chemotherapy. TNBC is a type of breast cancer where certain common treatments don't work because the cancer cells lack specific markers. The study wants to see if a drug called celecoxib (known as Celebrex in some places) can help stop the cancer from returning during and after radiotherapy. Radiotherapy can sometimes cause the body to release signals that might encourage cancer cells to spread. Celecoxib aims to block these signals. This is a small initial study to check if it's practical to run a larger study, and to find out if celecoxib actually changes these body signals.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Université de Sherbrooke

Enrolment target

Start

04 Aug 2025

Estimated completion

04 Aug 2032

Triple-Negative Breast Cancer

What is this study about?

This study is investigating a new approach for women with a type of breast cancer called triple-negative breast cancer (TNBC). Triple-negative means the cancer cells don't have three specific features (receptors) that many other breast cancers have. Because of this, some common cancer treatments, like hormone therapy or HER2-targeted therapies, aren't effective for TNBC, making it a more challenging type to treat. Even after initial treatments like surgery and chemotherapy, there's a risk that TNBC could come back.

After breast cancer is removed, radiotherapy is often used to help kill any remaining cancer cells in the breast area. However, sometimes radiotherapy can cause the body to release certain natural chemicals, called cytokines, which, in some cases, might actually encourage any leftover cancer cells to spread. This study is looking at whether a drug called celecoxib (also known by the brand name Celebrex) can prevent this from happening.

Celecoxib works by blocking a specific pathway in the body. The researchers believe that taking celecoxib during radiotherapy might help to reduce these potentially harmful cytokines, therefore reducing the chances of the cancer spreading or returning. This is a "pilot study," which means it's a small, initial investigation to see if this idea is practical and worth studying on a larger scale. The main goal is to figure out if it's possible to recruit enough patients and follow the study steps, and to also see if celecoxib has the desired effect on these body chemicals.

Key takeaways

Tests celecoxib for preventing triple-negative breast cancer recurrence.
Aims to block radiotherapy-induced signals that might promote cancer spread.
This is a small initial study to check feasibility for a larger trial.
Participation involves taking daily capsules for about 6 weeks.
Regular follow-up for 5 years to monitor your health.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with early-stage triple-negative breast cancer. You must have had your main cancer removed by surgery and have finished chemotherapy if you had it. The cancer should not have spread to other parts of your body, and your doctor must confirm it is triple-negative.

There are certain health conditions that would prevent you from joining. For example, if you have had stomach ulcers, certain kidney or liver problems, or serious heart failure recently. You also can't take part if you are already taking certain anti-inflammatory medications regularly, like ibuprofen, or if you have known allergies to celecoxib or similar drugs, or if you have inflammatory bowel disease.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and 18 years or older?
Do you have early-stage triple-negative breast cancer?
Have you had surgery to remove your primary tumour?
Do you have no evidence of the cancer having spread to distant parts of your body?
Do you not regularly take medications like ibuprofen or other anti-inflammatory drugs?
Have you not had a stomach ulcer or significant kidney/liver/heart problems recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take one capsule of either celecoxib or a placebo (a dummy pill with no active drug) twice a day – once after breakfast and once after supper. You'll start taking these pills 7 days before your radiotherapy begins and continue for 14 days after your radiotherapy ends. In total, you'll take the study medication for no longer than 40 days.

Your radiotherapy schedule will be determined by your doctors. You'll keep a diary (logbook) to record when you take your medication and if you experience any side effects like skin rashes, headaches, or dizziness. You will have blood tests at different times (before, during, and after radiotherapy) to check the levels of certain chemicals in your body. After your treatment, you'll be followed up for 5 years, which will include yearly clinic visits and mammograms. If your breast tissue is very dense, you might also have an MRI scan every other year. Other scans like CT or PET scans will only be done if you develop new symptoms, such as bone pain.

Potential risks and benefits

Participating in this study might offer a potential benefit if celecoxib helps to reduce the risk of your breast cancer returning, although this is not guaranteed and is what the study aims to find out. There are potential risks associated with taking celecoxib, such as stomach problems, headaches, or skin rashes, and these will be monitored closely. Like with any medication, there could be other, less common side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Faculty of medicine and health sciences
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is triple-negative breast cancer?

It's a type of breast cancer where the cancer cells don't have three common markers, which means certain targeted treatments won't work for it.

What is celecoxib (Celebrex)?

It's a drug often used to relieve pain and swelling, but in this study, scientists are looking at whether it can help prevent cancer from returning.

What is a placebo?

A placebo is a dummy pill that looks just like the study drug but contains no active medicine. It helps researchers compare the active drug's effects fairly.

Will I know if I'm getting celecoxib or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over, to keep the results fair.

How long will I be followed up after treatment?

You will be followed up for 5 years after your treatment, with regular check-ups and scans as part of your standard care.

How to find out more

Benoit Paquette, Ph.D.

benoit.paquette@usherbrooke.ca 1-819-821-8000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.