Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

July 28, 2016 updated by: University of Michigan Rogel Cancer Center

UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with breast cancer

Description

Inclusion Criteria:

  1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
  2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
  3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
  4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.

  5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.

    -

Exclusion Criteria:

  1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
  2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
  3. 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.

  4. Patients with another active systemic malignancy in the past year.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
women with breast cancer
Procedure: tissue procurement
tissue procurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Anne F. Schott, M.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2004.064
  • IRB # 2005-009 and HUM 44194 (Other Identifier: University of Michigan Medical IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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