Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age46-55
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

> 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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Dual X-ray Absorptiometry
  • Functional Assessment
  • Lifestyle Counseling
  • Semaglutide

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator