This trial is active, not recruiting.

Condition breast cancer
Treatment tissue procurement
Sponsor University of Michigan Cancer Center
Start date May 2005
End date August 2012
Trial size 75 participants
Trial identifier NCT00161265, IRB # 2005-009 and HUM 44194, UMCC 2004.064


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
women with breast cancer
tissue procurement
tissue procurement

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
Principal investigator Anne F. Schott, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.