Actively Recruiting
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Led by Jules Bordet Institute · Updated on 2025-06-13
112
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
J
Jules Bordet Institute
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer. To contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug. Our goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and/or eliminating residual disease using repurposing drugs
CONDITIONS
Official Title
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Female
- Weight of at least 35 kg
- Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive according to local testing
- Tumor size of 1.5 cm or larger determined by ultrasound or MRI/CT scan
- Stage I, II, or III breast cancer (non-metastatic)
- For multifocal or bilateral breast cancer, all tumors must be estrogen receptor positive
- Scheduled for primary breast cancer surgery
- Willing to provide plasma/blood and tumor samples for research
- Willing to provide tissue from a new core or excisional biopsy for central analysis
- Willing to take omeprazole with no contraindications
- Hemostasis screening with HEMSTOP score less than 2 and normal coagulation tests
- Women of childbearing potential agree to use highly effective contraception during and for at least one month after treatment
- Negative pregnancy test within 30 days before starting treatment
- Able and willing to provide written informed consent
You will not qualify if you...
- Planned intraoperative radiotherapy or immediate reconstruction
- Receiving neoadjuvant breast cancer therapy
- Allergy to NSAIDs or gabapentinoids
- Known hypersensitivity to study treatments or related substances including peanut or soya
- Current use of certain medications including thiazolidinedione, lithium salts, probenecid, pentoxifylline, or intensive diuretics
- Current use of NSAIDs more than twice a week in the year before diagnosis or use of pregabalin
- Previous cancer within 5 years except certain skin cancers or in situ cervical cancer
- Active or history of peptic ulcer disease or gastrointestinal bleeding
- Pregnant or breastfeeding
- Chronic inflammatory diseases such as rheumatoid arthritis, asthma, heart failure, COPD, inflammatory bowel disease, multiple sclerosis, lupus, and others
- Nasal polyposis syndrome, Quincke's edema, bronchospasm, or asthma
- Active chronic infectious diseases such as hepatitis B or C, active tuberculosis
- Uncontrolled or certain treated HIV infections
- Current infection treated with specific antifungal or antibiotic drugs unless stopped 10 days before treatment
- Inadequate liver function
- Cirrhosis or severe hepatitis
- Renal impairment or single kidney or previous renal surgery
- History of severe renal toxicity with NSAIDs
- Recent surgeries with high risk of bleeding
- Cardiovascular disease or uncontrolled high blood pressure
- Hemostasis disorders or current/planned anticoagulant or anti-platelet therapy
- Inadequate bone marrow function
- Systemic immunosuppressive treatment within 2 years prior diagnosis
- Psychiatric disease or use of antipsychotic/antidepressant drugs
- Epilepsy or current anti-epileptic drug use
- Obstructive sleep apnea
- ASA score 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut Jules Bordet
Brussels, Brussels Capital, Belgium, 1170
Actively Recruiting
Research Team
I
Imane Bachir, MD
CONTACT
M
Marion Maetens, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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