RecruitingPhase 2NCT06150898

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity

Sponsor

Jules Bordet Institute

Enrollment

112 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial (KePreSt) is studying whether two drugs — ketorolac (an anti-inflammatory painkiller) and pregabalin (a nerve pain medication) — taken around the time of breast cancer surgery might affect how the cancer behaves. There is scientific interest in whether these drugs could reduce the stress response from surgery and potentially influence cancer outcomes. **You may be eligible if...** - You are a woman aged 18–70 with a confirmed diagnosis of estrogen receptor-positive (ER+) invasive breast cancer - Your tumor is at least 1.5 cm in size and the cancer is stage I, II, or III (not spread to distant organs) - You are scheduled for primary breast cancer surgery - You are willing to provide blood and tissue samples for research **You may NOT be eligible if...** - You are planned for intraoperative radiation, immediate breast reconstruction, or neoadjuvant (pre-surgery) chemotherapy - You have an allergy to NSAIDs (like ibuprofen) or gabapentin/pregabalin-type drugs - You have a history of peptic ulcer disease, gastrointestinal bleeding, or kidney problems - You have significant heart, liver, or blood clotting problems - You are pregnant, breastfeeding, or have epilepsy - You use antipsychotic, antidepressant, or anti-epileptic medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProspective data and sample collection

Core-needle biopsy of the breast (pre-treatment), surgical sample collection (post-treatment), extra collection of blood samples (pre- and post-treatment), measurements of adiposity, lifestyle questionaire

DRUGKetorolac 10 Mg Oral Tablet

Patients will receive 10 mg film-coated tablets of ketorolac tromethamine three times a day, for five days before the surgery

DRUGPregabalin 75mg

Patients will receive 75 mg of pregabalin hard capsule twice a day, for seven days before the surgery

DRUGOmeprazole 20mg Capsule

Patients will receive 20 mg of omeprazole once a day on an empty stomach, for five days before the surgery

Locations(1)

Institut Jules Bordet

Brussels, Brussels Capital, Belgium

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NCT06150898