Tirzepatide Weight Loss for MRD+ Early Breast Cancer

Exclusion Criteria

• •1. Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
• •2. Treatment with a GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months
• •3. History of severe hypersensitivity reaction to GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies
• •4. Insulin-dependent diabetes
• •5. Has clinical evidence of diabetic retinopathy
• •6. Clinical evidence or suspicion of metastatic breast cancer
• •7. Current or past invasive cancers, other than breast cancer, are not allowed except for:
• •1. Adequately treated basal or squamous cell carcinoma of the skin
• •2. Previously diagnosed invasive cancer treated with curative intent, with no evidence of disease recurrence for at least 5 years, and are considered low risk for future recurrence by the treating physician
• •8. Patients with a second synchronous primary HER2-positive or triple negative breast cancer
• •9. Has an active infection requiring systemic therapy
• •10. Has a known history of human immunodeficiency virus (HIV) or active or persistent hepatitis B or hepatitis C virus
• •11. Has significant cardiovascular disease, such as:
• •1. History of stroke, myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months
• •2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.
• •12. Has a known history of active tuberculosis
• •13. Women who are pregnant or lactating. All patients of reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug
• •14. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
• •1. severe impaired lung functions as defined as spirometry and diffusing capacity of lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
• •2. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)
• •3. history of gastroparesis, impaired gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea vomiting and/or diarrhea, malabsorption syndrome, or small bowel resection)
• •15. Has a history of pancreatitis or current symptoms of untreated cholelithiasis
• •16. Has a family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or medullary thyroid cancer (MTC)
• •17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or results in trial participation not being in the patient's best interest, in the opinion of the Treating Physician
• •18. Has received an investigational agent within 4 weeks prior to study treatment; investigational monoclonal antibodies should have a 4-week (28 day) or 5 half-life washout period
• •19. Any other investigational or anti-cancer treatments while participating in this study with the exception of standard adjuvant endocrine therapy, zoledronic acid, or denosumab