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

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.

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.