Can two everyday drugs make breast cancer surgery safer?

NCT ID NCT06150898

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 09, 2026 · Last updated Oct 09, 2026

Summary

Researchers at the Jules Bordet Institute are studying whether two existing drugs, the painkiller ketorolac and the nerve drug pregabalin, can reduce inflammation and nerve signals around breast cancer surgery. The trial enrolls 112 women with early-stage, estrogen-receptor-positive breast cancer. Participants take the drugs before surgery, and researchers compare blood and tumor samples to see how the body's inflammatory and nervous system responses change.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketorolac and pregabalin, two existing drugs given before breast cancer surgery
What this could lead to
If the approach works, it could point to a low-cost way to make the time around breast cancer surgery less friendly to cancer spread.
What could go wrong
This is a small Phase 2 study measuring lab markers, not survival. The drugs may not change those markers, and pregabalin can cause drowsiness or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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\<2 and conventional coagulation screening test within normal limits such as activated partial thromboplastin time (21.6\< aPTT \>28.7), international normalised ratio (1.31\<INR) and platelet count (\>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\<1.2 mg/dl) - unless documented Gilbert syndrome- AND Alanine Aminotransferase (ALT) ≥ 2 x ULN (ULN \<32 UI/l and ULN \<33 UI/l, respectively) AND Alkaline phosphatase (ALP) ≥ 2.5 x ULN (ULN=104 UI/l)) 17. Cirrhosis or severe hepatitis. 18. Renal impairment (defined as GFR\<90ml/min/1.73m² or serum creatinine \> 442 μmol/l or \> 5 mg/dL) or single kidney or previous renal surgery 19. Subject with history of (severe) renal toxicity with an NSAID 20. Subject with a recent history of operations associated with a high risk of bleeding 21. Previous, ongoing or suspected cardiovascular disease defined as history of ischemic heart disease or heart failure or uncontrolled high blood pressure (Systolic ≥160mmHg and/or diastolic ≥100mmHg) or peripheral arterial disease or cerebrovascular disease 22. Subject with a recent history of surgery associated with a high risk of bleeding 23. Hemostasis disorder as haemophilia, Von Willebrand disease, constitutional thrombopathies or thrombocytopenia (defined as platelet count \< 100 000/mm³), current /planned anticoagulant or anti-platelet therapy. 24. Inadequate bone marrow function (defined as absolute neutrophil count \<1000/μL and platelet count \<100'000/μL) 25. Systemic immunosuppressive treatment (defined as systemic corticotherapy or anti-rejection treatment or interferon therapy) within the 2-years prior diagnosis 26. Psychiatric disease or antipsychotic/ antidepressant use 27. Epilepsy or any current anti-epileptic drug use 28. Obstructive sleep apnea 29. ASA≥3

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Institut Jules Bordet

    RECRUITING

    Brussels, 1170, Belgium

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