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 aged 18 or older, of any sex
• People diagnosed within the past 15 years with breast cancer that has spread to the lymph nodes, is hormone receptor-positive (ER+ greater than 10%), and is HER2-negative, as defined by standard medical guidelines
• People with cancer in both breasts at the same time (synchronous bilateral) may be eligible, with tissue from both tumours submitted for genetic testing
• People with multiple tumour sites in the same breast may be eligible, with the largest tumour submitted for genetic testing, provided all tumour sites have ER greater than 10%
• For people who received treatment before surgery, the hormone receptor and HER2 status of the tissue taken after treatment (not before) will determine eligibility
• People with a body mass index (BMI) greater than 27 kg/m², meaning they are classified as overweight or obese
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (confirm with trial site)
• People who have completed at least one year of standard hormone-based therapy given before or after their main cancer treatment; those prescribed a CDK 4/6 inhibitor must have completed that treatment
• People who have tested positive for circulating tumour DNA (ctDNA) — a blood test that can detect tiny amounts of cancer-related genetic material — using a specific test called the Haystack MRD assay
• People who have stored tumour tissue available (in a standard preservation format called FFPE) to allow genetic analysis for the ctDNA monitoring process
• People with no signs of cancer that has spread to other parts of the body, based on physical checks, blood tests, and imaging scans after the positive ctDNA result
• People with adequate blood cell counts, including white blood cells, platelets, and haemoglobin levels within acceptable ranges (confirm specific values with trial site)
• People with adequate liver function based on standard blood tests (confirm specific values with trial site)
• People with adequate kidney function based on standard blood tests (confirm specific values with trial site)
• People who are able to attend treatment sessions and follow-up appointments
• People who understand the research nature of the study and are willing to give written consent before joining

Who may not be able to join:

• People who have had weight-loss surgery or procedures (such as gastric sleeve or intragastric balloon) after their breast cancer diagnosis
• People who have used certain diabetes or weight-loss medications known as GLP-1 receptor agonists or related drug types within the past 3 months
• People who have had a severe allergic reaction to GLP-1 receptor agonist medications or related drug types
• People who require insulin to manage diabetes
• People with a confirmed diagnosis of diabetic eye disease (diabetic retinopathy)
• People with any clinical signs or suspicion that the breast cancer has spread to other parts of the body
• People with a current or past diagnosis of another invasive cancer, with exceptions for: certain treated skin cancers, or cancers treated with curative intent where there has been no sign of the disease returning for at least 5 years and the treating doctor considers the risk of recurrence to be low
• People who also have a second breast cancer that is HER2-positive or triple-negative at the same time
• People with an active infection currently requiring treatment with systemic medications
• People with a known history of HIV, or active or persistent hepatitis B or hepatitis C
• People with significant heart or cardiovascular conditions, including a stroke, heart attack, or heart procedure in the past 6 months, or moderate-to-severe heart failure
• People with a known history of active tuberculosis
• People who are pregnant or breastfeeding; people of reproductive potential must agree to use effective contraception from the time of joining the trial until at least 3 months after the last dose of the study drug
• People with severely reduced lung function or low oxygen levels at rest
• People with serious liver disease, such as cirrhosis or severe liver impairment
• People with a history of slow stomach emptying (gastroparesis), significant digestive conditions, or bowel diseases that could affect how the study drug is absorbed
• People with a history of pancreatitis or currently untreated gallstones
• People with a family history of a condition called Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or medullary thyroid cancer
• People whose treating doctor believes participation would not be in their best interest or could interfere with study results
• People who have taken part in another clinical trial or received an experimental treatment within the 4 weeks before starting this study (or longer, depending on the type of treatment — confirm with trial site)
• People receiving any other experimental or anti-cancer treatments during the study, apart from standard hormone therapy, or certain bone-protecting medications (zoledronic acid or denosumab)

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