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Recruiting NCT06150898

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

Conditions: Early-stage Breast Cancer, Estrogen-receptor-positive Breast Cancer

Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 112
Sponsor: Jules Bordet Institute

Location: Institut Jules Bordet Brussels

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 Criteria

Inclusion Criteria: Subjects must meet all of the following criteria in order to be eligible for this study: 1. Age ≥ 18 years and ≤ 70 years old 2. Female 3. Weight ≥ 35 kg 4. 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 5. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI/CT scan. 6. Stage I, II or III disease (non-metastatic) 7. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing 8. Subject scheduled for a primary breast cancer surgery 9. Subject is willing to provide plasma/blood and tumour samples for translational research. 10. Subject is willing to provide tissue from a newly obtained core or excisional biopsy of the tumour that should be evaluable for central histological characterization and future molecular testing 11. Subject is willing to take omeprazole and has no contraindication to omeprazole. 12. Have an HEMSTOP score\28.7), international normalised ratio (1.31\100.10³/ml) 13. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least one months after the last administration of study treatment. 14. Negative serum pregnancy test for women of childbearing potential (within 30 days before start of treatment) 15. Subject is willing and able to provide written informed consent for the trial Exclusion Criteria: Subjects meeting one of the following criteria are not eligible for this study: 1. Subject planned for intraoperative radiotherapy 2. Subject planned for immediate reconstruction 3. Neoadjuvant BC therapy 4. Allergy to any NSAID or gabapentinoïd 5. Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications. Hypersensitive to peanut or soya (related to propofol contraindications) 6. Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy. 7. Current NSAID (\> twice a week the year prior to diagnosis) or pregabalin use 8. Previous malignant pathology within 5 years prior to inclusion or currently undergoing maintenance therapy. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer. 9. Active or history of peptic ulcer disease or gastro-intestinal bleeding or perforation 10. Pregnancy or lactating women 11. Chronic inflammatory disease as rheumatoid arthritis, uncontrolled asthma, chronic heart failure, chronic obstructive pulmonary disease, cystic fibrosis, inflammatory myopathies (e.g., idiopathic polymyositis, dermatomyositis, inclusion body myositis), inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), McArdle's disease, multiple sclerosis, lupus, chronic inflammatory demyelinating polyneuropathy, psoriasis, autoimmune thyroiditis as Graves' disease or Hashimoto's thyroiditis (unless previous surgical ablation), myasthenia gravis, vasculitis. 12. Complete or partial nasal polyposis syndrome, Quincke's oedema, bronchospasm, asthma 13. Known chronic infectious disease as active hepatitis B (defined as positive serology for Ac anti-HBc and IgM anti HBc OR Ac anti HBc and Ag HBs), active hepatitis C (defined as positive serology for anti-VHC and positive PCR-VHC) or active tuberculosis (included under treatment) 14. Uncontrolled HIV infection (defined as detectable viral loads by standard clinical assays) or controlled HIV infection (defined undetectable HIV viral loads by standard clinical assays) treated by one of following drugs: Nelfinavir, Atazanavir or Saquinavir (related to interaction with omeprazole). 15. Infection currently treated with one of the following drugs: posaconazole, voriconazole, ketoconazole and rifampicin, unless discontinuation of treatment is planned at least 10 days prior to the start of study treatment AND with complete resolution according to expert opinion (related to interaction with omeprazole) 16. Inadequate liver function (defined as total serum bilirubin ≥ 2 x upper limit of normal (ULN\

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Source: ClinicalTrials.gov (NCT06150898). StuddyBuddy aggregates publicly available trial information.