30 Participants Needed

Celecoxib for Breast Cancer

BP
HT
Overseen ByHélène Therriault, M.Sc.
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Université de Sherbrooke
Must be taking: Celecoxib
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether celecoxib, a medication typically used for pain relief, can prevent the spread of triple-negative breast cancer (TNBC) during radiotherapy. Researchers aim to determine if celecoxib can inhibit certain proteins, called cytokines, from promoting cancer spread during radiotherapy. The trial compares celecoxib to a placebo (a pill with no active medicine) to assess its effects on cancer cell behavior. Women who have had early-stage TNBC with no sign of cancer spread and have completed surgery might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking an NSAID (a type of pain reliever) before starting radiotherapy. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that celecoxib is generally safe for people. Studies have found no major safety differences between those taking celecoxib and those taking a placebo, which is a pill with no active ingredients. For instance, one study found that the survival rate, or the percentage of people still alive after a certain time, was similar for both groups. Specifically, 90% of people taking celecoxib were alive after five years, compared to 91% of those taking the placebo.

The FDA has already approved celecoxib for other uses, such as pain relief, indicating it has passed safety checks for those conditions. While this doesn't guarantee safety for breast cancer treatment, it is a positive sign. Most people tolerate celecoxib well, but like any drug, it can still cause side effects. Always consult a doctor about any concerns.12345

Why do researchers think this study treatment might be promising for breast cancer?

Celecoxib is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that targets COX-2 enzymes, potentially reducing inflammation associated with breast cancer. Unlike traditional breast cancer treatments, which often include chemotherapy, hormone therapy, and targeted therapies, celecoxib works by addressing the inflammatory processes that can support cancer growth. Researchers are excited about its potential to enhance the effectiveness of radiotherapy while possibly minimizing side effects, as it is already well-known for its safety profile in treating conditions like arthritis.

What evidence suggests that celecoxib might be an effective treatment for triple-negative breast cancer?

Research suggests that celecoxib, which participants in this trial may receive, might help treat breast cancer by slowing the growth of cancer cells. Some studies have shown that celecoxib could be useful in cancer treatment, especially in early laboratory tests. However, other research found no major difference in results between those taking celecoxib and those taking a placebo, another treatment arm in this trial. While celecoxib offers hope due to its effects on inflammation, the evidence remains mixed. More research is needed to confirm its effectiveness in treating triple-negative breast cancer.12367

Who Is on the Research Team?

BP

Benoit Paquette, Ph.D.

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for patients with early-stage triple-negative breast cancer, which lacks three specific receptors. Participants should not have had a relapse and must be scheduled to receive radiotherapy. The study aims to recruit individuals who can follow the study steps for future larger-scale research.

Inclusion Criteria

I am female.
My cancer has not spread to distant parts of my body.
I am 18 years old or older.
See 4 more

Exclusion Criteria

Participants with proven hyperkalemia
Participants with a history of asthma attacks, urticaria, or allergic reactions after taking acetylsalicylic acid or another nonsteroidal anti-inflammatory drug
I have inflammatory bowel disease.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy and Celecoxib Administration

Participants receive radiotherapy and take celecoxib or placebo starting 7 days before radiotherapy and ending 14 days after radiotherapy

Up to 45 days
4 plasma sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including annual clinical examinations and mammograms

5 years
Annual visits

What Are the Treatments Tested in This Trial?

Interventions

  • Celecoxib
Trial Overview The trial tests whether Celecoxib, a COX-2 inhibitor, can prevent an increase in cytokines that promote metastasis when given during radiotherapy. Patients will either receive Celecoxib or a placebo while their cytokine levels are monitored before, during, and after treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Celecoxib (celebrex)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+

Citations

Celecoxib in breast cancer prevention and therapy - PMCThus, celecoxib shows an anticancer activity and seems to be effective in anticancer treatment. Bocca et al assessed the antiproliferative activity of celecoxib ...
Effect of Celecoxib vs Placebo as Adjuvant Therapy on ...Disease-free survival events were reported for 487 patients (19%): 18% for those receiving celecoxib vs 19% for those receiving placebo, a ...
Celecoxib may be a viable treatment option for breast ...Celecoxib has shown efficacy in preclinical studies of breast cancer and also as a chemopreventive agent in epidemiological investigations.
Triple Negative Breast Cancer and Celecoxib. Pilot StudyPlasma samples collected 14 days after radiotherapy will help determine whether celecoxib's protective effect persists over time.
The Efficacy and Safety of Celecoxib in Addition ...Only one study reported OS in breast cancer (HR = 1.71, 95%CI = 0.88–3.33), which indicated that celecoxib-combined neoadjuvant therapy had no effect on OS.
Celecoxib Safe, but Not Effective, for Breast CancerThere were also no differences in OS between the two groups, with 5-year OS of 90% in the celecoxib group and 91% in the placebo group. ER ...
Celecoxib targets breast cancer stem cells by inhibiting the ...Our findings suggest that celecoxib, by targeting CSCs, may be used as an adjuvant chemotherapy drug to improve breast cancer treatment outcomes ...
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