Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517212
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Tirzepatide in Patients With Obesity or Overweight Who Have High Risk Early Breast Cancer and Are ctDNA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of 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:
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:
None
Brief Summary:
This trial aims to asses if tirzepatide-induced weight loss of 10 body weight 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 of 10 body weight will 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 of 10 body weight will 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 of 10 body weight will 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 of 10 body weight will 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?:
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