Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular, cancer
- Who it enrolls
- age 46 Years to 55 Years; female; excludes diabetes; BMI ≥30 required; conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
- Interventions
- Biospecimen Collection; Dual X-ray Absorptiometry; Functional Assessment; Lifestyle Counseling; Semaglutide
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
- Phase and size
- Phase 4 · 50 participants
- Dates
- Start 2026-09-01
Primary completion 2031-07-30 - Sponsor
- Mayo Clinic (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in PWV between arms (Aim 1)Baseline to 24 weeks
- Change in protein expression between arms (Aim 2a)Baseline to 24 weeks
- Significantly enriched biological pathways and gene sets among DEPs (Aim 2b)Up to 24 weeks
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.