Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00161265
First received: September 8, 2005
Last updated: July 24, 2012
Last verified: July 2012
History of Changes

September 8, 2005
July 24, 2012
May 2005
May 2015   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00161265 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

tissue
Non-Probability Sample

women with breast cancer
Breast Cancer
Procedure: tissue procurement
tissue procurement
1
women with breast cancer
Intervention: Procedure: tissue procurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
May 2015
May 2015   (final data collection date for primary outcome measure)

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.

    -
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161265
UMCC 2004.064, IRB # 2005-009 and HUM 44194
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Anne F. Schott, M.D. University of Michigan Cancer Center
University of Michigan Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP