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New treatment option for Early-stage Breast Cancer
Official title Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
ClinicalTrials.gov ID: NCT06150898
What this study is testing
What is Ketorolac 10 Mg Oral Tablet?
Ketorolac 10 Mg Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for early-stage breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- people must meet all of the following criteria in order to be eligible for this study:
- 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...
You likely can't join if
- people meeting one of the following criteria are not eligible for this study:
- Subject planned for intraoperative radiotherapy
- Subject planned for immediate reconstruction
- Neoadjuvant BC therapy
- Allergy to any NSAID or gabapentinoïd
- Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications...
See the full eligibility criteria
Who can join
- people must meet all of the following criteria in order to be eligible for this study:
- 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...
- Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI/CT scan.
- Stage I, II or III disease (non-metastatic)
- In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing
- Subject scheduled for a primary breast cancer surgery
- Subject is willing to provide plasma/blood and tumour samples for translational research.
- 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
- Subject is willing to take omeprazole and has no contraindication to omeprazole.
- Have an HEMSTOP score\ 28.7), international normalised ratio (1.31\ 100.10³/ml)
- 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...
- Negative serum pregnancy test for women of childbearing potential (within 30 days before start of treatment)
- Subject is willing and able to provide written informed consent for the trial
What rules you out
- people meeting one of the following criteria are not eligible for this study:
- Subject planned for intraoperative radiotherapy
- Subject planned for immediate reconstruction
- Neoadjuvant BC therapy
- Allergy to any NSAID or gabapentinoïd
- 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)
- Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy.
- Current NSAID (\> twice a week the year prior to diagnosis) or pregabalin use
- 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...
- Active or history of peptic ulcer disease or gastro-intestinal bleeding or perforation
- Pregnancy or lactating women
- Chronic inflammatory disease as rheumatoid arthritis, uncontrolled asthma, chronic heart failure, chronic obstructive pulmonary disease, cystic fibrosis, inflammatory myopathies (e.g., idiopathic polymyositis...
- Complete or partial nasal polyposis syndrome, Quincke's oedema, bronchospasm, asthma
- 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...
- 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...
- 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...
- 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...
- Cirrhosis or severe hepatitis.
- Renal impairment (defined as GFR\ 442 μmol/l or \> 5 mg/dL) or single kidney or previous renal surgery
- Subject with history of (severe) renal toxicity with an NSAID
- Subject with a recent history of operations associated with a high risk of bleeding
- 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...
- Subject with a recent history of surgery associated with a high risk of bleeding
- 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.
- Inadequate bone marrow function (defined as absolute neutrophil count \<1000/μL and platelet count \<100'000/μL)
- Systemic immunosuppressive treatment (defined as systemic corticotherapy or anti-rejection treatment or interferon therapy) within the 2-years prior diagnosis
- Psychiatric disease or antipsychotic/ antidepressant use
- Epilepsy or any current anti-epileptic drug use
- Obstructive sleep apnea
- ASA≥3
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Brussels Capital, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Brussels Capital, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.