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New treatment option for Triple-Negative Breast Cancer
Official title Triple Negative Breast Cancer and Celecoxib. Pilot Study
ClinicalTrials.gov ID: NCT07104266
What this study is testing
What is Celecoxib (Celebrex)?
Celecoxib (Celebrex) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for triple-negative breast cancer.
Also referred to as Chemotherapy, radiotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female
- Age: 18 years or older
- Tumor stage: Early
- TNBC status confirmed by pathology
- Regional lymph node N0 to N3
You likely can't join 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...
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.