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1B-13-2 Core Biopsies of Breast Tumor Tissue Repository

Description

The response to treatment varies considerably among breast cancer patients. Markers that can predict response to specific therapies have been difficult to identify and validate for several reasons: cell and animal models do not reflect human biology well, tumor tissue that has been fixed in preservative limits their analysis, and differences within tumors that may control drug response are not easily assessed in tissue sections. The study of human breast tumor tissue in patients at baseline and at timepoints following medical therapies can provide valuable insights into markers and pathways that mediate drug response and resistance. We aim to create a repository for future studies to develop and refine tissue assays and to generate pilot data on mediators of drug response/resistance that can then be validated on larger tissue cohorts from clinical trial databases and other outside repositories. In contrast to the more general breast and womens program tissue repository, this proposal is specifically for collecting core tumor biopsies performed on patients with breast cancers who are receiving anti-cancer therapy. The objective of this proposal is to prospectively obtain and bank core biopsies of breast cancers at the timepoints of diagnostic biopsy, surgery for tumor removal, and following chemotherapy in order to facilitate research focusing on tumor changes that drive drug resistance and spread to other organs.Patients enrolled in this registry will have suspected or known breast cancer and be able to provide additional core biopsy specimens over and above those needed for diagnosis and other required tests. There will be 4 groups of patients enrolled: 1) patients newly diagnosed with early stage breast cancer who will have surgery before receiving any chemotherapy, 2) patients newly diagnosed with breast cancer who will be receiving standard of care chemotherapy before surgery or patients with advanced disease that cannot be removed with surgery, 3) patients being evaluated for a suspicious breast mass that has a high likelihood of being cancer, and 4) patients with breast cancer that has returned or worsened. Consenting patients will have additional core needle biopsies of suspected or known breast tumors collected by the pathologist assigned to the case. Up to 6 additional core biopsies will be obtained through a single opening in the skin under ultrasound guidance by the research radiologist. For patients in whom a full diagnosis is not yet established, the additional core biopsy specimens will be held until the pathologist verifies that the diagnostic biopsy is sufficient for all needed diagnostic tests. If patients consent, another set of biopsies will be done at the time when their disease returns or worsens. Blood samples will be collected at baseline and at the time when disease returns or worsens. Medical records will be reviewed to collect information about medical history, family history, diagnosis, cancer treatments, lab test results, medications used, tumor measurements, and death. Participants will be followed every 6 months through chart review and telephone calls.Interested investigators and / or researchers who would like to obtain tissue or blood samples and / or associated data will submit their IRB-approved protocols for consideration to the Core Biopsy Steering Committee.

Phase

N/A

Inclusion and Exclusion Criteria

  • Known or suspected breast cancer

  • Inability to sign informed consent
  • Known bleeding disorder
  • Use of anticoagulant medications (heparin, warfarin, etc.) within one week prior to biopsy
  • Use of antiplatelet medications (aspirin, clopidogrel, etc.) within one week prior to biopsy

Sites

Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.

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