Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorJules Bordet Institute
About this trial
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 criteria
Qualifiers
Age ≥ 18 years and ≤ 70 years old
Female
Weight ≥ 35 kg
Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and/or Allred score of 3 or more
Disqualifiers
Subject planned for intraoperative radiotherapy
Subject planned for immediate reconstruction
Neoadjuvant BC therapy
Allergy to any NSAID or gabapentinoïd
Trial design
Treatments tested in this trial
- Prospective data and sample collection
- Ketorolac 10 Mg Oral Tablet
- Pregabalin 75mg
- Omeprazole 20mg Capsule
Treatment groups
112 Participants
are divided into 4 treatment groupsSponsors and collaborators
Jules Bordet Institute
Lead sponsor
KU Leuven
Collaborator
Source ClinicalTrials.gov