Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT02250352

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cytology specimen collection procedure

Study Details

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

Study ID

NCT02250352

Start date

Nov 14, 2013

Status verified date

May, 2026

Completion date

Nov 14, 2027

Anticipated

Primary completion date

Nov 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

cytology specimen collection procedure

Correlative studies

Primary outcome measure

  • Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Zeno Ashai

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

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ameria Casillas-Lopez

323-865-0804America.Casillas-Lopez@med.usc.edu

Principal Investigator:

Julie Lang, M.D.

More Information

Sponsor

University of Southern California

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-05-13.