NCT06150898: 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

Recruiting now Phase 2 Last updated 10 June 2025

What this trial tests

Phase 2 trial testing Prospective data and sample collection in Early-stage Breast Cancer in 112 participants. Currently enrolling.

Timeline

12 May 2025

Primary endpoint
20 April 2027

1 October 2027

Quick facts

Lead sponsor	Jules Bordet Institute
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	112
Start date	12 May 2025
Primary completion	20 April 2027
Estimated completion	1 October 2027
Sites	1 location across Belgium

Drugs / interventions tested

• Prospective data and sample collection
• Ketorolac 10 Mg Oral Tablet — full drug profile →
• Pregabalin 75mg — full drug profile →
• Omeprazole 20mg Capsule

Conditions studied

• Early-stage Breast Cancer — all drugs for Early-stage Breast Cancer →
• Estrogen-receptor-positive Breast Cancer — all drugs for Estrogen-receptor-positive Breast Cancer →

Sponsor

Jules Bordet Institute

Who can join

Adults 18 to 70, female only, with Early-stage Breast Cancer or Estrogen-receptor-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac
  Time frame: Up to 24 hours after surgery
  Plasma multiplex technology using cytometric bead arrays
• To detect a reduced increase in systemic neurotransmitters (from baseline to up to 24 hours after surgery) using peri-operative pregabalin
  Time frame: Up to 24 hours after surgery
  Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
• Change in biomarkers of metastasis at surgery from baseline
  Time frame: At surgery
  Transcriptome profile and bioinformatic analysis
• Change in tumoral immune cells recruitment at surgery from baseline
  Time frame: At surgery
  Characterization of Tumour-infiltrating leukocyte subpopulations using RNA sequencing analysis from fresh frozen tissue sections
• Change in tumoral neurogenesis at surgery from baseline
  Time frame: At surgery
  Level of neurogenesis markers using RNA sequencing analysis from fresh frozen tissue section
• Change in tumoral neurotransmitters level at surgery from baseline
  Time frame: At surgery
  Using RNA sequencing analysis from fresh frozen tissue sections

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunotherapy targeting the obese white adipose tissue microenvironment: Focus on non-communicable diseases.
   Priscilla L, Yoo C, Jang S, Park S, et al · · 2024 · cited 8× · PMID 38404641 · DOI 10.1016/j.bioactmat.2024.01.027