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Clinical Trials/NCT02455882
NCT02455882
Terminated
Not Applicable

Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer

University of Michigan1 site in 1 country14 target enrollmentMay 30, 2014
ConditionsBreast 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.

Registry
clinicaltrials.gov
Start Date
May 30, 2014
End Date
April 7, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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