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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07769047
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
46 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Dual X-ray Absorptiometry — PROCEDURE
    Undergo DEXA
  • Functional Assessment — OTHER
    Undergo vascular function testing
  • Lifestyle Counseling — BEHAVIORAL
    Receive structured lifestyle intervention recommendations
  • Semaglutide — DRUG
    Given SC

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Jul 30, 2031
Completion
Jul 30, 2035

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Arm I (LM)
    Patients receive recommendations for a structured lifestyle intervention over 24 weeks consisting of the following: 1) a low-calorie diet based on their Harris-Benedict predicted resting energy expenditure, reduced by 500 kcal/day; (2) a physical activity goal of ≥ 10,000 steps/day; (3) ≥ 150 minutes per week of moderate-intensity aerobic exercise with resistance training; and (4) limited liquid calorie intake (e.g., sodas, juices, alcohol). Additionally, patients undergo blood sample collection, vascular function testing, and DEXA on study.
  • Experimental: Arm II (LM+Sema)
    Patients receive recommendations for a structured lifestyle intervention over 24 weeks consisting of the following: 1) a low-calorie diet based on their Harris-Benedict predicted resting energy expenditure, reduced by 500 kcal/day; (2) a physical activity goal of ≥ 10,000 steps/day; (3) ≥ 150 minutes per week of moderate-intensity aerobic exercise with resistance training; and (4) limited liquid calorie intake (e.g., sodas, juices, alcohol). Patients also receive semaglutide SC QW for up to 24 weeks in the absence of unacceptable toxicity. Additionally, patients undergo blood sample collection, vascular function testing, and DEXA on study.

Primary Outcome Measure

Change in PWV between arms (Aim 1) [ Time Frame: Baseline to 24 weeks ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • General Clinical Studies Unit
    904-953-2255

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
General Clinical Studies Unit
904-953-2255
Maria Daniela Hurtado Andrade, MD, PhD (PRINCIPAL_INVESTIGATOR)

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