Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 46 Years to 55 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding semaglutide, a weight-loss medicine, to food and exercise counseling improves heart and blood vessel health. It is for breast cancer survivors ages 46–55 who have obesity, are past menopause, and take an aromatase inhibitor, a medicine that lowers estrogen.
This phase IV trial studies whether adding semaglutide to structured lifestyle support improves heart and blood vessel health in postmenopausal obese breast cancer survivors (BCS) who are taking an aromatase inhibitor. In postmenopausal BCS who are taking an aromatase inhibitor, obesity raises the risk of heart and blood vessel problems. Semaglutide is a medicine approved by the United States Food and Drug Administration for weight loss and for lowering the risk of heart events in people with heart disease. The structured lifestyle support in this trial includes counseling on nutrition and physical activity which provides specific recommendations for individuals to follow.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Breast cancer was diagnosed after natural menopause, meaning periods had stopped for at least 12 months.
- Breast cancer was diagnosed within the past 5 years.
- Breast cancer is stage 1, 2, or 3.
- Age 46–55.
- Body mass index (BMI), a measure of weight compared with height, is 30 or higher.
- Currently taking an aromatase inhibitor.
- Able to take part in all study activities and willing to give yourself injections.
Who can't join
- Weight changed by more than 5% in the past 3 months or by at least 20 pounds in the past 6 months; or menopause began before age 46.
- Past heart or blood vessel disease, stroke, smoking, or diabetes; taking a statin cholesterol medicine; or a calculated 10-year heart and blood vessel disease risk above 7.5%.
- A parent, sibling, or child had heart or blood vessel disease before age 45 for males or 55 for females; or you received chemotherapy, radiation, or immune-based treatment for breast cancer.
- Severely reduced kidney function (GFR 30 or lower), certain low-thyroid test results (TSH at least 7 with low free T4), or hemoglobin below 11. Hemoglobin carries oxygen in blood.
- Active inflammation, disease in which the immune system attacks the body, infection, liver or digestive disease, cancer, or an uncontrolled mental health condition.
- Weight-loss medicine used in the past 3 months; past or planned weight-loss surgery; or certain past or planned procedures using a scope or device. Liposuction or a tummy tuck done more than a year ago does not exclude you.
- Use in the past 3 months of medicines that may cause weight gain, or steroid treatment acting throughout the body for more than 2 weeks; or a medical reason you cannot take GLP-1 medicines such as semaglutide.
- Currently in another study testing an experimental product, or received study treatment or a placebo in such a study within the past 30 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Breast cancer diagnosed after menopause (menopause defined as the natural/spontaneous cessation of menses for at least 12 months) * Breast cancer (BC) diagnosed within the past five years * BC stage 1, 2, or 3 * Aged 46-55 years * Body mass index (BMI) ≥ 30 kg/m\^² * Current use of an aromatase inhibitor * Ability to participate in all portions of the study, including willingness to self-inject Exclusion Criteria: * \> 5% change in weight during the 3 months prior to screening and/or weight fluctuation of ≥ 20 pounds within the past 6 months (self-report) * Early menopause (menopause occurring before age 46) * History of established cardiovascular disease, including coronary atherosclerosis, ischemic heart disease, peripheral vascular disease, or stroke * Statin use * 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk \> 7.5% * History of smoking * History of type 1 or type 2 diabetes * Family history of premature cardiovascular disease in a first-degree relative (before 45 years old in male relatives and before 55 years old in female relatives) * Use of chemotherapy, radiation therapy, or immunotherapy for breast cancer treatment * Impaired renal function \[glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m\^²\] * Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4) * Hemoglobin \< 11 mg/dL * Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease * Other anti-obesity medication used within the past 3 months * Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \> 1 year before screening) * Past or intended endoscopic and/or device-based therapy or removal within the last six months * Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers * Current or recent use (within 3 months) of systemic glucocorticoid therapy for over 2 weeks * Contraindications to glucagon-like peptide 1 (GLP-1) receptor agonist therapy * Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days
Study sites (1)
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224-9980General Clinical Studies Unit · Study contact · 904-953-2255Maria Daniela Hurtado Andrade, MD, PhD · Principal investigatorMore trials in Jacksonville