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.
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
> 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
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Dual X-ray Absorptiometry
Procedure/SurgeryUndergo DEXA
Functional Assessment
Other interventionUndergo vascular function testing
Lifestyle Counseling
BehavioralReceive structured lifestyle intervention recommendations
Semaglutide
DrugGiven SC
Change in PWV between arms (Aim 1)
Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.
Change in protein expression between arms (Aim 2a)
Will assess the change in protein expression from baseline to 24 weeks between arms. The raw protein concentrations for all samples will be reported in Normalized Protein eXpression (NPX) values, as obtained from the OLINK platform . A log2 scale transformation will be applied to the NPX values to stabilize variance across samples and allow data to be comparable.
Significantly enriched biological pathways and gene sets among DEPs (Aim 2b)
Will identify biological pathways and gene sets significantly enriched among the differentially expressed proteins (DEPs) between arms.
Change in AIx between arms (Aim 1)
Will assess the difference in augmentation index (AIx) from baseline to 24 weeks between arms.
Change in RHI between arms (Aim 1)
Will assess the difference in reactive hyperemic index (RHI)from baseline to 24 weeks between arms.
Change in PWV within arms (Aim 1)
Will assess the change in pulse wave velocity (PWV) from baseline to 24 weeks within each arm.
Change in AIx within arms (Aim 1)
Will assess the change in AIx from baseline to 24 weeks within each arm.
Examine functional significance of semaglutide-induced DEPs through enrichment analysis (Aim 2b)
Will use enrichment analysis to assess semaglutide-induced DEP profiles for correlation with functional categories (e.g., inflammatory response, metabolic function, vascular remodeling, atherogenesis).
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
