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

NCT02455882 | Terminated DMC

• 1 other identifier: HUM00084633
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Collection of samples for analysis of somatic mutations

  Mutations in the tumor before and after primary systemic therapy will be examined

  5 years

Secondary Outcomes (1)

• Collection of samples for analysis of circulating biomarkers

  5 years

Study Arms (3)

Neoadjuvant

Patients initiating standard of care treatment with primary systemic therapy for breast cancer

Adjuvant

Patients initiating standard of care treatment with surgery followed by adjuvant chemotherapy for breast cancer

Recurrence

Patients with a history of breast cancer who are diagnosed with disease recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present with newly diagnosed breast cancer or breast cancer recurrence.

You may qualify if:

• 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.

You may not qualify if:

• \- 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)
• 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.
• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue with invasive disease, blood, and urine samples will be obtained from patients with breast cancer before, during, and after systemic treatment for primary breast cancer and at the time of disease recurrence.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erin F Cobain, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Internal Medicine

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: May 30, 2014
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

US (1)