IRB Study Number 24-104
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
The primary objective of the study is to evaluate the clinical validity of a ctDNA-based MRD test designed to detect breast cancer progression or recurrence following surgery.
2.2 Secondary Objectives
The secondary objectives of the study are to:
• Evaluate the lead time between ctDNA-based MRD detection and clinical recurrence as detected by standard of care following surgery.
• Assess the association of ctDNA levels with changes over time in detecting clinical recurrence and/or tumor progression following surgery.
• Evaluate the association of ctDNA-based MRD detection and distal recurrence following surgery.
Inclusion Criteria
• Age 18 years or older or age of majority in state of residence
• A first diagnosis of invasive breast cancer
• Planning to undergo surgical treatment for curative intent
• Planning to undergo regular follow-up and standard-of-care recurrence monitoring
• T1-4
• ER/PR/HER2 status known
• If (HR+/HER2-), patient must be eligible for chemotherapy
Exclusion Criteria
• Metastatic disease or currently active additional cancer diagnosis (except non-melanoma skin cancer or a secondary breast cancer at the time of diagnosis)
• Previous allogeneic organ or tissue transplant
