Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT02455882
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of samples for analysis of somatic mutations 5 years Mutations in the tumor before and after primary systemic therapy will be examined
- Secondary Outcome Measures
Name Time Method Collection of samples for analysis of circulating biomarkers 5 years Change in circulating biomarkers, including extracellular DNA and RNA, over time will be examined
Trial Locations
- Locations (1)
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States