A Phase 4 interventional study of Biospecimen Collection and Dual X-ray Absorptiometry in Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to female participants aged 46 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Supportive care
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Among 160 studies in Breast Neoplasms by Mayo Clinic — 30 open to participants now, 41 under way, 1 of them phase 3. Breast Neoplasms · Mayo Clinic.
Among the 160 studies in Breast Neoplasms by Mayo Clinic, this one is the 43rd largest by planned enrollment of the 97 interventional ones that give a count, is one of 4 that started in 2026, is the only one in phase 4, reaches primary completion later than 36 of the 40 other live ones, and was the 160th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →30 of the 160 studies in Breast Neoplasms by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–50 · Women only
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+ · Women only
Mayo Clinic · Sites in United States
Ages 18–100 · Women only · Healthy volunteers
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 46 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
160 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 30 · Phase 3 4 · Phase 4 1
First in 1997; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 48 across the 97 interventional studies, 95 across the 62 observational. Of the 110 that completed or were terminated, 29 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
18 of the studies in Breast Neoplasms by Mayo Clinic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04443413Phase 3Mayo ClinicPhase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients | 2026-11-19 |
| NCT06557057Mayo ClinicImpact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk | 2026-12-01 |
| NCT06831838Mayo ClinicA Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors | 2026-12-31 |
| NCT04692818Mayo Clinic3D Ultrasound Breast Imaging | 2026-12-31 |
| NCT07285044Mayo ClinicThe Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas | 2027-05-15 |
Add all 18 to your calendar (.ics) → With an account.
Among the 160 studies in Breast Neoplasms by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Procedure: Dual X-ray Absorptiometry · Other: Functional Assessment · Behavioral: Lifestyle Counseling
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.
Procedure: Biospecimen Collection · Procedure: Dual X-ray Absorptiometry · Other: Functional Assessment · Behavioral: Lifestyle Counseling · Drug: Semaglutide
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo DEXA
Also known as: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN
Undergo vascular function testing
Receive structured lifestyle intervention recommendations
Given SC
Also known as: Ozempic, Rybelsus, Wegovy
Change in PWV between arms (Aim 1)
Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 weeks
Change in AIx between arms (Aim 1)
Will assess the difference in augmentation index (AIx) from baseline to 24 weeks between arms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 weeks
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).
Time frame: Up to 24 weeks
Start is estimated for Sep 2026; primary completion for Jul 2031, 58 months later.
Of 110 non-industry phase 4 interventional studies under Breast Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 64. This study's planned 58 months is above that.
Counting every sponsor, half of 130 studies reached it within 42 months; a quarter within 20 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide