Core Biopsies for Establishing a Breast Tumor Tissue Repository

NCT02250352 | Recruiting DMC

• 4 other identifiers: 1B-13-2NCI-2014-01932HS-13-00342P30CA014089
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program

  Up to 10 years

• Development and maintenance of a secure clinical database of relevant demographic, clinical, pathologic, and longitudinal outcome characteristics of the samples to be banked

  Up to 10 years

• Development of an efficient process for the distribution of de-identified samples from the bank to researchers with IRB-approved protocols or exemptions for the study of breast cancer-related questions

  Up to 10 years

Study Arms (5)

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.

Other: cytology specimen collection procedure

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.

Other: cytology specimen collection procedure

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.

Other: cytology specimen collection procedure

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.

Other: cytology specimen collection procedure

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.

Other: cytology specimen collection procedure

Interventions

cytology specimen collection procedure OTHER

Correlative studies

Also known as: cytologic sampling

Cohort I (newly diagnosed, surgery before systemic therapy); Cohort II (newly diagnosed, systemic therapy before surgery); Cohort III (patients with suspicious breast mass); Cohort IV (breast cancer recurrence or progression); Cohort V (solid tumor suspicious of originating from breast primary)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects seen at USC Norris Comprehensive Cancer Center and LAC+USC Medical Center will be recruited for this trial.

You may qualify if:

• Known or suspected breast cancer
• Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Southern California: lead

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Evanthia Roussos-Torres, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeno Ashai

CONTACT

323-865-0463; zeno.ashai@med.usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: November 14, 2013
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)