Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06517212
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
Adjuvant Tirzepatide Plus Standard of Care Endocrine Therapy in Patients With Obesity or Overweight Who Have Hormone Receptor-positive, HER2-negative, Node-positive Early Breast Cancer, With Molecular Residual Disease (MRD), as Determined by Circulating Tumor DNA (ctDNA)
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIM-EBC
Brief Summary:
This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.
Detailed Description:
The goal of this clinical trial is to learn if tirzepatide induced weight loss effects survival outcomes in high risk early breast cancer patients. The main questions it aims to answer are:
1. Does tirzepatide-induced weight loss lead to clearance of plasma ctDNA in the adjuvant setting in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence, and
2. Does tirzepatide-induced weight loss prevent the development of overt metastatic disease and improve distant disease-free survival, in the two-year period following first detection of ctDNA in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence.
Researchers will assess clinical outcomes after the first 20 patients are enrolled and have taken tirzepatide for at least 6 months. If at least three of the first 20 evaluable patients demonstrate clearance of ctDNA on tirzepatide, or at least ten of the first 20 patients remain alive and free of distant metastatic disease during the two-year period following initial detection of ctDNA using the Kaplan-Meier method, an additional 28 ctDNA-positive patients will be enrolled.
Patients will screen for ctDNA every 3 months for up to 3 years or until ctDNA positivity, whichever comes first. Once positive, they will undergo radiologic imaging to confirm the absence of frank metastatic disease. If confirmed, patients will receive tirzepatide once weekly for up to 2 years, visit the clinic monthly for the first 6 months, and every other month thereafter.
1. Does tirzepatide-induced weight loss lead to clearance of plasma ctDNA in the adjuvant setting in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence, and
2. Does tirzepatide-induced weight loss prevent the development of overt metastatic disease and improve distant disease-free survival, in the two-year period following first detection of ctDNA in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence.
Researchers will assess clinical outcomes after the first 20 patients are enrolled and have taken tirzepatide for at least 6 months. If at least three of the first 20 evaluable patients demonstrate clearance of ctDNA on tirzepatide, or at least ten of the first 20 patients remain alive and free of distant metastatic disease during the two-year period following initial detection of ctDNA using the Kaplan-Meier method, an additional 28 ctDNA-positive patients will be enrolled.
Patients will screen for ctDNA every 3 months for up to 3 years or until ctDNA positivity, whichever comes first. Once positive, they will undergo radiologic imaging to confirm the absence of frank metastatic disease. If confirmed, patients will receive tirzepatide once weekly for up to 2 years, visit the clinic monthly for the first 6 months, and every other month thereafter.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: