Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518837
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor PositiveHER2 Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FITWISE Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor PositiveHER2 Negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FITWISE
Brief Summary:
This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5 or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive HER2-negative HRHer2- breast cancer The study will also assess the safety and tolerability of tirzepatide its feasibility based on discontinuation rates and completion of treatment Secondary objectives include evaluating 3-year invasive disease-free survival IDFS and distant relapse-free survival DRFS changes in BMI and body fat distribution metabolic markers and circulating tumor DNA ctDNA
Detailed Description:
The primary objective of this clinical trial is to determine the proportion of patients who achieve a 5 or greater reduction in body weight by the end of the study treatment with tirzepatide during adjuvant treatment for hormone receptor-positive HER2-negative HRHer2- breast cancer Secondary objectives include assessing the safety and tolerability of tirzepatide for weight loss during this treatment The feasibility of using tirzepatide for weight loss intervention will be evaluated through discontinuation rates and completion of the treatment course Additionally the trial will determine the 3-year invasive disease-free survival IDFS and 3-year distant relapse-free survival DRFS with the use of tirzepatide The study will also assess changes in Body Mass Index BMI body fat distribution measured via WaistHip Ratio WHR and waist circumference and obesity-related metabolic markers including Blood Pressure fasting insulin fasting blood glucose HgbA1c cholesterol LDL HDL triglycerides IGF1 estrogen and testosterone Finally the trial will monitor for circulating tumor DNA ctDNA and assess changes when using tirzepatide for weight loss in the adjuvant treatment of HRHer2- breast cancer Quality of Life assessments will be obtained and exploratory objectives investigating adipokines adiponectin leptin and their receptors metabolomic pathways and immune cell metabolism will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None