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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002385 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants completing week 24 visit with all required assessments | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline to week 24 | Baseline, 24 weeks | |
| Absolute change in visceral fat mass from baseline to week 24 | As assessed by SECA scan | Baseline, 24 weeks |
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Inclusion Criteria:
Biologically female
Age ≥ 18
Obesity as defined by current BMI ≥ 30 kg/m²
Postmenopausal as defined by one or more of the following
HR+ (ER and/or PR) stage 0-III breast cancer
Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
Insurance approval for tirzepatide or willing to pay out of pocket
Willing to provide informed consent and comply with study procedures
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lynelle Weis | Contact | 646-962-2423 | ljw4002@med.cornell.edu | |
| Henry Cheng | Contact | 646-962-6026 | hec4011@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Schmitz, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Percent change in visceral fat mass from baseline to week 24 | As assessed by SECA scan | Baseline, 24 weeks |
| Absolute change in fasting glucose from baseline to week 24 | Baseline, 24 weeks |
| Percent change in fasting glucose from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in fasting insulin from baseline to week 24 | Baseline, 24 weeks |
| Percent change in fasting insulin from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in hemoglobin A1c from baseline to week 24 | Baseline, 24 weeks |
| Percent change in hemoglobin A1c from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in IGF-1 from baseline to week 24 | Baseline, 24 weeks |
| Percent change in IGF-1 from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in leptin from baseline to week 24 | Baseline, 24 weeks |
| Percent change in leptin from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in adiponectin from baseline to week 24 | Baseline, 24 weeks |
| Percent change in adiponectin from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in hs-CRP from baseline to week 24 | Baseline, 24 weeks |
| Percent change in hs-CRP from baseline to week 24 | Baseline, 24 weeks |
| Absolute change in ghrelin from baseline to week 24 | Baseline, 24 weeks |
| Percent change in ghrelin from baseline to week 24 | Baseline, 24 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |