An observational study in Breast Cancer, sponsored by University of Michigan. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by University of Michigan · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 14 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who present with newly diagnosed breast cancer or breast cancer recurrence.
Entry Criteria for patients receiving neoadjuvant or adjuvant therapy (groups 1 and 2)
Inclusion Criteria
Exclusion Criteria - For the neoadjuvant cohort (group 1): Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave at least 2 cm of measurable disease by physical examination, mammography, or ultrasound (with the exception of inflammatory breast cancer)
Entry Criteria for patients with newly diagnosed locoregional or distant disease recurrence (who did not enroll at the time of initial adjuvant or neoadjuvant chemotherapy) (group 3)
Inclusion Criteria
Exclusion Criteria
Patients initiating standard of care treatment with primary systemic therapy for breast cancer
Patients initiating standard of care treatment with surgery followed by adjuvant chemotherapy for breast cancer
Patients with a history of breast cancer who are diagnosed with disease recurrence
Collection of samples for analysis of somatic mutations
Mutations in the tumor before and after primary systemic therapy will be examined
Time frame: 5 years
Collection of samples for analysis of circulating biomarkers
Change in circulating biomarkers, including extracellular DNA and RNA, over time will be examined
Time frame: 5 years
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Michigan