Anatomic Stage I Breast Cancer AJCC v8Phase 4NCT07769047
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
A Phase 4 study testing Biospecimen Collection, Dual X-ray Absorptiometry and Functional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 46 to 55 years, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Dual X-ray Absorptiometry and Functional Assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jul 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- > 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
General Clinical Studies Unit contact
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
General Clinical Studies Unit, 904-953-2255
Maria Daniela Hurtado Andrade, MD, PhD
About this study
Official title: Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease
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.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Biospecimen Collection, Dual X-ray Absorptiometry, Functional Assessment, Lifestyle Counseling, Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)
Undergo DEXA
Functional AssessmentOther
Undergo vascular function testing
Lifestyle CounselingBehavioural
Receive structured lifestyle intervention recommendations
SemaglutideDrug
Also called Ozempic, Rybelsus, Wegovy
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (LM) | Active comparator | 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. Receives: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Other: Functional Assessment; Behavioral: Lifestyle Counseling |
| Arm II (LM+Sema) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Other: Functional Assessment; Behavioral: Lifestyle Counseling; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PWV between arms (Aim 1)
Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.
Measured: 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.
Measured: Baseline to 24 weeks
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.
Measured: Up to 24 weeks
Secondary outcomes (23)
Change in AIx between arms (Aim 1)
Will assess the difference in augmentation index (AIx) from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in RHI between arms (Aim 1)
Will assess the difference in reactive hyperemic index (RHI)from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in PWV within arms (Aim 1)
Will assess the change in pulse wave velocity (PWV) from baseline to 24 weeks within each arm.
Measured: Baseline to 24 weeks
Change in AIx within arms (Aim 1)
Will assess the change in AIx from baseline to 24 weeks within each arm.
Measured: Baseline to 24 weeks
Change in RHI within arms (Aim 1)
Will assess the change in RHI from baseline to 24 weeks within each arm.
Measured: Baseline to 24 weeks
Change in body weight between arms (Aim 1)
Will assess the difference in change in body weight from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in fat mass between arms (Aim 1)
Will assess the difference in change in total fat mass and visceral fat mass from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in waist and hip circumference between arms (Aim 1)
Will assess the difference in change in waist and hip circumference from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in blood pressure between arms (Aim 1)
Will assess the difference in change in systolic and/or diastolic blood pressure from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in total cholesterol between arms (Aim 1)
Will assess the difference in change in total cholesterol from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in LDL-cholesterol between arms (Aim 1)
Will assess the difference in change in LDL-cholesterol from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in HDL-cholesterol between arms (Aim 1)
Will assess the difference in change in HDL-cholesterol from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in triglycerides between arms (Aim 1)
Will assess the difference in change in triglycerides from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in fasting glucose parameters between arms (Aim 1)
Will assess the difference in change in fasting glucose from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in HbA1c between arms (Aim 1)
Will assess the difference in change in HbA1c from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in hs-CRP between arms (Aim 1)
Will assess the difference in change in high-sensitivity (hs) C-reactive protein (CRP) (hs-CRP) from baseline to 24 weeks between arms.
Measured: Baseline to 24 weeks
Change in protein expression within arms (Aim 2a)
Will assess the change in protein expression from baseline to 24 weeks within each arm.
Measured: Baseline to 24 weeks
Difference in protein expression between arms at baseline (Aim 2a)
Will assess the difference in protein expression at baseline between arms.
Measured: At baseline
Difference in protein expression between arms at 24 weeks (Aim 2a)
Will assess the difference in protein expression at 24 weeks between arms.
Measured: At 24 weeks
Overlap of change in protein expression within arms (Aim 2a)
Will assess overlap between the two arms in change in protein expression within each arm at baseline and at 24 weeks.
Measured: At baseline and 24 weeks
Key hub proteins as central regulators in semaglutide-mediated effects (Aim 2b)
Will identify key hub proteins that may serve as central regulators in semaglutide-mediated effects.
Measured: Up to 24 weeks
Network connectivity between DEPs and known molecular pathways (Aim 2b)
Will assess network connectivity between DEPs and known molecular pathways relevant to metabolic and vascular function.
Measured: Up to 24 weeks
Overlap of DEPs and established cardiovascular risk biomarkers (Aim 2b)
Will evaluate the overlap between DEPs and established cardiovascular risk biomarkers.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Maria Daniela Hurtado Andrade, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769047
- Sponsor's protocol ID
- 25-012266
- Other IDs
- K23HL183845, NCI-2026-04536
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07769047
- Acronym / sponsor ID
- 25-012266
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Jul 2035 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (LM) | Active comparator | Procedure: Biospecimen Collection, Procedure: Dual X-ray Absorptiometry, Other: Functional Assessment, Behavioral: Lifestyle CounselingPatients 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. |
| Arm II (LM+Sema) | Experimental | Procedure: Biospecimen Collection, Procedure: Dual X-ray Absorptiometry, Other: Functional Assessment, Behavioral: Lifestyle Counseling, Drug: SemaglutidePatients 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. |
Who may qualify
- Ages
- 46 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- > 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (LM), Arm II (LM+Sema) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)Undergo DEXA | Procedure or surgery | Arm I (LM), Arm II (LM+Sema) |
| Functional AssessmentUndergo vascular function testing | Other | Arm I (LM), Arm II (LM+Sema) |
| Lifestyle CounselingReceive structured lifestyle intervention recommendations | Behavioural | Arm I (LM), Arm II (LM+Sema) |
| SemaglutideAlso: Ozempic, Rybelsus, WegovyGiven SC | Drug | Arm II (LM+Sema) |
Primary outcome
Change in PWV between arms (Aim 1)
Time frame: Baseline to 24 weeks
Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.
Change in protein expression between arms (Aim 2a)
Time frame: Baseline to 24 weeks
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)
Time frame: Up to 24 weeks
Will identify biological pathways and gene sets significantly enriched among the differentially expressed proteins (DEPs) between arms.
23 secondary outcomes
Change in AIx between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in RHI between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in PWV within arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in AIx within arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in RHI within arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in body weight between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in fat mass between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in waist and hip circumference between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in blood pressure between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in total cholesterol between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in LDL-cholesterol between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in HDL-cholesterol between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in triglycerides between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in fasting glucose parameters between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in HbA1c between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in hs-CRP between arms (Aim 1)
Time frame: Baseline to 24 weeks
Change in protein expression within arms (Aim 2a)
Time frame: Baseline to 24 weeks
Difference in protein expression between arms at baseline (Aim 2a)
Time frame: At baseline
Difference in protein expression between arms at 24 weeks (Aim 2a)
Time frame: At 24 weeks
Overlap of change in protein expression within arms (Aim 2a)
Time frame: At baseline and 24 weeks
Key hub proteins as central regulators in semaglutide-mediated effects (Aim 2b)
Time frame: Up to 24 weeks
Network connectivity between DEPs and known molecular pathways (Aim 2b)
Time frame: Up to 24 weeks
Overlap of DEPs and established cardiovascular risk biomarkers (Aim 2b)
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
General Clinical Studies Unit contact
Maria Daniela Hurtado Andrade, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biospecimen Collection, Dual X-ray Absorptiometry and Functional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PWV between arms (Aim 1) (time frame: Baseline to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.