Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Michigan
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Collection of samples for analysis of somatic mutations
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
Through the investigators' Breast Care Center at the University of Michigan Comprehensive Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant chemotherapy. The majority of the remainder of patients with stage II and III disease undergo treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care. There is a subset of women with ER positive disease who do not receive chemotherapy because of favorable tumor characteristics.
This tissue procurement protocol is designed to systematically collect tissue, urine and blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy, serially following treatment, and/or at the time of disease recurrence in order to investigate mechanisms underlying development of metastatic disease, to identify predictors of response and resistance to therapy, and to test potential new therapies for breast cancer using a combination of patient-derived xenograft creation and new microfluidic technologies.
Investigators
Erin Cobain
Clinical Lecturer in Internal Medicine
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Collection of samples for analysis of somatic mutations
Time Frame: 5 years
Mutations in the tumor before and after primary systemic therapy will be examined
Secondary Outcomes
- Collection of samples for analysis of circulating biomarkers(5 years)