Core Biopsies of Breast Tumor Tissue Repository
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
This research trial establishes a breast tumor tissue repository from core biopsies. Collecting breast tissue from core biopsies may allow doctors to learn more about the biology of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may also allow doctors to conduct future studies to help understand how breast cancer grows and how it responds to different types of therapy. This will help doctors develop better breast cancer therapies and better tests to help make treatment decisions.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Known or suspected breast cancer
• Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history
Locations
United States
California
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Zeno Ashai
zeno.ashai@med.usc.edu
323-865-0463
Time Frame
Start Date: 2013-11-14
Estimated Completion Date: 2027-11-14
Participants
Target number of participants: 400
Treatments
Cohort I (newly diagnosed, surgery before systemic therapy)
Patients undergo baseline and, if applicable, follow-up core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases. Patients who experience a recurrence or progression after therapy undergo additional core biopsies at the time of recurrence. Blood and tissue sample collections will also be gathered along with completion of surveys.
Cohort II (newly diagnosed, systemic therapy before surgery)
Patients undergo core biopsy, blood and tissue sample collections, and completion of surveys. Patients also undergo biopsies at a specific time point following the initiation of standard systemic therapy.
Cohort III (patients with suspicious breast mass)
Patients undergo core biopsy, blood and tissue sample collections, and surveys. Patients who have BIRADS 4b, 4c, and 5 lesions may undergo up to 6 additional 6 core biopsies.
Cohort IV (breast cancer recurrence or progression)
Patients undergo core biopsy, blood and tissue sample collections, and completion of surveys. Patients may also undergo 1-3 extra core biopsies.
Cohort V (solid tumor suspicious of originating from breast primary)
Patients will undergo a confirmatory biopsy for diagnosis in which 1-3 additional core biopsies will be obtained for research purposes. Patients will also undergo blood and tissue sample collections and completion of surveys.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Southern California
Collaborators: National Cancer Institute (NCI)