Phase 2 Obesity Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are aged between 18 and 70 years old
• People who are female
• People who weigh at least 35 kg
• People who have been diagnosed with a type of invasive breast cancer (called invasive breast adenocarcinoma) that responds to the hormone oestrogen, confirmed by a tissue sample test
• People whose tumour measures at least 1.5 cm, as measured by ultrasound, MRI, or CT scan
• People whose cancer is at Stage I, II, or III (meaning it has not spread to other parts of the body)
• People who have multiple tumour areas in one or both breasts, as long as all areas are oestrogen-receptor positive
• People who are already scheduled to have surgery to remove their breast cancer
• People who are willing to provide blood and tumour tissue samples for research purposes
• People who are willing to provide a fresh tissue sample from their tumour for laboratory testing
• People who are willing to take a stomach-protecting medication called omeprazole and have no medical reason to avoid it
• People whose blood clotting test results fall within the normal ranges specified by the trial (confirm with trial site)
• Women who could become pregnant and agree to use a highly effective form of contraception before, during, and for at least one month after the trial treatment ends
• Women who could become pregnant and have had a negative pregnancy blood test within 30 days before starting treatment
• People who are willing and able to sign a written consent form agreeing to take part in the trial

Who may not be able to join:

• People who are planned to receive radiation therapy during their surgery (intraoperative radiotherapy)
• People who are planned to have immediate breast reconstruction surgery
• People who have already received chemotherapy, hormone therapy, or other treatments for their breast cancer before surgery (neoadjuvant therapy)
• People who are allergic to anti-inflammatory medications (NSAIDs) or a type of nerve-pain medication called gabapentinoids
• People who have had a known allergic reaction to any of the study medications or their ingredients, or who are allergic to peanuts or soya
• People currently taking certain medications, including a diabetes drug called thiazolidinedione, lithium, probenecid, pentoxifylline, or high-dose water tablets (diuretics)
• People who are currently taking anti-inflammatory medications (NSAIDs) more than twice a week, or who are currently taking pregabalin (a nerve-pain medication)
• People who have had another cancer in the past 5 years, or who are currently on ongoing cancer treatment — with some exceptions for certain treated skin cancers or cervical changes (confirm with trial site)
• People who have a history of stomach ulcers, stomach or intestinal bleeding, or a hole (perforation) in the stomach or intestine
• People who are pregnant or currently breastfeeding
• People who have certain ongoing inflammatory or autoimmune conditions, such as rheumatoid arthritis, uncontrolled asthma, heart failure, chronic lung disease, inflammatory bowel disease, lupus, multiple sclerosis, or several other listed conditions (confirm with trial site for the full list)
• People who have nasal polyps, a history of severe allergic swelling (Quincke's oedema), bronchospasm, or asthma
• People with certain active infectious diseases, including active hepatitis B, active hepatitis C, or active tuberculosis
• People with uncontrolled HIV infection, or people with controlled HIV who are taking specific medications that interact with omeprazole (Nelfinavir, Atazanavir, or Saquinavir)
• People currently being treated with certain antifungal or antibiotic medications (posaconazole, voriconazole, ketoconazole, or rifampicin), unless those medications will be stopped at least 10 days before the trial starts
• People with poor liver function, as measured by specific blood test results above the levels set by the trial (confirm with trial site)
• People with cirrhosis or severe liver disease
• People with reduced kidney function, a single kidney, or previous kidney surgery, as defined by specific blood test results (confirm with trial site)
• People who have previously had serious kidney side effects from anti-inflammatory medications (NSAIDs)
• People who have recently had surgery that carried a high risk of bleeding
• People with a history of heart disease, heart failure, uncontrolled high blood pressure, artery disease, or stroke
• People with a bleeding or clotting disorder such as haemophilia, Von Willebrand disease, or low platelet counts, or who are currently taking or planning to take blood-thinning or anti-clotting medications
• People with low bone marrow function, as shown by specific blood test results (confirm with trial site)
• People who have been on immune-suppressing treatments (such as steroids or anti-rejection medications) within the 2 years before diagnosis
• People with a psychiatric condition or who are taking antipsychotic or antidepressant medications
• People with epilepsy or who are currently taking any anti-epilepsy medications
• People with obstructive sleep apnoea
• People whose general health status is rated at a certain level of medical risk under a standard surgical scoring system (ASA score of 3 or above — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.