Core Biopsies for Establishing a Breast Tumor Tissue Repository
NCT ID: NCT02250352
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2013-11-14
2027-11-14
Brief Summary
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Detailed Description
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I. To develop a baseline and serial breast cancer core biopsy repository within the University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer Program.
II. To develop and maintain a secure clinical database of relevant demographic, clinical, pathologic and longitudinal outcome characteristics of the samples to be banked.
III. To have an efficient process for the distribution of de-identified samples from the bank to researchers with institutional review board (IRB)-approved protocols or exemptions for the study of breast cancer-related questions. These studies would include analyses of tumor proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune cells in relationship to other baseline and follow-up clinical and pathological variables.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT I (PATIENTS WITH NEWLY DIAGNOSED EARLY STAGE BREAST CANCER WHO WILL UNDERGO DEFINITIVE SURGERY BEFORE ANY 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. Clinical and blood specimens will also be gathered.
COHORT II (PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER WHO WILL RECEIVE STANDARD OF CARE SYSTEMIC THERAPY BEFORE SURGERY OR PATIENTS WITH ADVANCED UNRESECTABLE DISEASE): Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also undergo biopsies at a specific time point following the initiation of standard systemic therapy.
COHORT III (PATIENTS BEING EVALUATED FOR A SUSPICIOUS BREAST MASS THAT HAS A HIGH LIKELIHOOD OF BEING CANCER): Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients who have Breast Imaging-Reporting and Data System (BIRADS) 4b, 4c, and 5 lesions may undergo up to 6 additional 6 core biopsies.
COHORT IV (PATIENTS WITH BREAST CANCER RECURRENCE OR PROGRESSION \[LOCAL, REGIONAL, OR DISTANT/METASTATIC\]): Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients may also undergo 1-3 extra core biopsies.
After completion of study, patients are followed up every 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
cytology specimen collection procedure
Correlative studies
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.
cytology specimen collection procedure
Correlative studies
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.
cytology specimen collection procedure
Correlative studies
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.
cytology specimen collection procedure
Correlative studies
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.
cytology specimen collection procedure
Correlative studies
Interventions
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cytology specimen collection procedure
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Evanthia Roussos-Torres, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ameria Casillas-Lopez
Role: primary
Other Identifiers
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NCI-2014-01932
Identifier Type: REGISTRY
Identifier Source: secondary_id
HS-13-00342
Identifier Type: -
Identifier Source: secondary_id
1B-13-2
Identifier Type: OTHER
Identifier Source: secondary_id
1B-13-2
Identifier Type: -
Identifier Source: org_study_id