FITWISE

RecruitingPhase 2

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Lead sponsor

Rutgers, The State University of New Jersey

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Oncology

Key I/E criterion

—

Primary endpoint

•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06518837

Org study ID042403

Timeline

Milestones

Study first posted2024-07-24actual

Study start2024-10-30actual

Last update posted2026-01-21actual

Primary completion2027-09-30estimated

Study completion2027-09-30estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Consent: Be willing and able to provide written informed consent for the trial.

•Age: Male or Female patients aged 18 years or older.

•Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer previously diagnosed by biopsy. HR status is defined as estrogen receptor (ER) >10% and/or progesterone receptor (PR) >10%; HER2 status is defined as immunohistochemistry (IHC) 0 or 1+ or IHC 2+, fluorescence in situ hybridization (FISH) negative.

•Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer.

•Definitive Treatment: Have had definitive treatment with curative intent for breast cancer, including surgery, chemotherapy, and radiotherapy as indicated.

•Body Mass Index (BMI): Have a BMI of 30 kg/m² or more, or a BMI of 27 kg/m² or more with one weight-related complication (e.g., hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).

•Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

•Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% or greater, or greater than the institution's lower limit of normal (LLN), as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.

•Organ Function: Demonstrate adequate organ function in screening labs.

•Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides.

Exclusion criteria

•Other Clinical Studies: Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.

•Stage IV Breast Cancer: Have stage IV, metastatic breast cancer.

•Cancer Type: Have HER2-positive or triple-negative breast cancer.

•Active Malignancy: Have a concomitant active malignancy.

•Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.

•Body Mass Index: Have a BMI of less than 27 kg/m².

•Type 1 Diabetes Mellitus: Have type 1 diabetes mellitus.

•Gastric Emptying Abnormality: Have a known clinically important gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect gastrointestinal motility.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Other clinical outcomes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)

Time frame:Through study completion, total of two years.

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, as measured by Waist/Hip Ratio (WHR), and waist circumference.

Time frame:Obesity measurements will be evaluated through study completion for two years.

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Weight and height will be combined to report BMI in kg/m^2.

Time frame:Obesity measurements will be evaluated through study completion for two years.

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint/low confidence

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of fasting insulin changes, unit of Measure: Milli-international units per liter (mIU/L)

Time frame:Metabolic markers will be evaluated through study completion for two years.

change from baseline, improvement

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Fasting Blood Glucose Changes, Unit of Measure: Millimoles per liter (mmol/L)

Time frame:Metabolic markers will be evaluated through study completion for two years.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of HgbA1c Changes, Unit of Measure: Millimoles per mole (mmol/mol)

Time frame:Metabolic markers will be evaluated through study completion for two years.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Blood Pressure Changes unit of Measure: Millimeters of mercury (mm Hg).

Time frame:Metabolic markers will be evaluated through study completion for two years.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Cholesterol (Total, LDL, HDL) Changes Unit of Measure: Milligrams per deciliter (mg/dl)

Time frame:Metabolic markers will be evaluated through study completion for two years.

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Triglyceride Changes Unit of Measure: Millimoles per liter (mmol/L)

Time frame:Metabolic markers will be evaluated through study completion for two years.

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Safety and Tolerability of Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Incidence of Adverse Events Using CTCAE v5.0)

Time frame:Adverse events will be monitored through study completion for two years.

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint/low confidence

Feasibility of Tirzepatide for Weight Loss Intervention during Adjuvant Treatment for HR+/Her2- Breast Cancer (Assessed by Discontinuation Rates and Completion of Treatment Course).

Time frame:Feasibility will be evaluated through study completion for two years.

Discontinuation due to AE

threshold achievement, descriptive

componentsDiscontinuation due to AE, treatment completion

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint/low confidence

Clinical Efficacy of Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by 3-Year Invasive Disease-Free Survival and 3-Year Distant Relapse-Free Survival)

Time frame:Patients will be monitored for recurrence through study completion and an additional year, for total three years.

time to event, event

Secondary/protocol endpoint

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Testosterone Changes, Unit of Measure: Nanograms per deciliter (ng/dL)

Time frame:Metabolic markers will be evaluated through study completion for two years.

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Monitoring Circulating Tumor DNA (ctDNA) Levels Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Detection and Changes in ctDNA Levels during Treatment).

Time frame:ctDNA levels will be monitored through study completion for two years.

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of IGF1 Changes, Unit of Measure: Nanograms per milliliter (ng/ml)

Time frame:Metabolic markers will be evaluated through study completion for two years.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Estrogen Changes, Unit of Measure: Picograms per milliliter (pg/ml)

Time frame:Metabolic markers will be evaluated through study completion for two years.

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.