Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/14/2018 |
| Start Date: | May 30, 2014 |
| End Date: | April 7, 2017 |
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.
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.
Entry Criteria for patients receiving neoadjuvant or adjuvant therapy (groups 1 and 2)
Inclusion Criteria
- All patients must have a primary invasive breast cancer with the primary tumor intact
(T2-4, any N, any M). Inflammatory breast cancer is permitted.
- For the neoadjuvant cohort (group 1), the patient's clinical plan includes neoadjuvant
systemic therapy (chemotherapy, hormonal therapy, and/or biologic therapy) prior to
surgery on the breast.
- For the adjuvant cohort (group 2), the patient's clinical plan includes surgical
resection of the primary breast mass followed by adjuvant chemotherapy (with or
without endocrine therapy or biologic therapy such as trastuzumab).
- Patients in the neoadjuvant cohort must have had mammography performed at the
University of Michigan, OR outside film review prior to enrollment.
- All patients are required to sign an informed consent document regarding the
experimental purpose of the research biopsies and serum banking, in accordance with
the University of Michigan IRB standards.
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)
- For the adjuvant cohort (group 2): Tumors diagnosed by excisional or incisional biopsy
and which are not likely to have at least 2 cm of residual tumor remaining
- Patients must not have received any prior chemotherapy, hormonal therapy, or radiation
therapy for their current breast cancer. Patients who received tamoxifen or other
agents for prevention of breast cancer may be included.
- Patients with another active systemic malignancy within the past year.
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
- Patients must have been previously diagnosed with non-invasive or invasive breast
cancer.
- Patients must have been diagnosed with biopsy-proven recurrence of breast cancer at
any site
- All patients are required to sign an informed consent document regarding the
experimental purpose of the research biopsies and serum banking, in accordance with
the University of Michigan IRB standards.
Exclusion Criteria
- Patients must not have received any chemotherapy, hormonal therapy, or radiation
therapy for treatment of their recurrent breast cancer.
- Patients must not have been diagnosed with another active systemic malignancy within
the past year.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: N. Lynn Henry, MD, PhD
Phone: 734-936-6000
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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