Breast CancerNCT02250352
Core Biopsies for Establishing a Breast Tumor Tissue Repository
An observational study of Breast Cancer, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cytology specimen collection procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2013to 14 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects seen at USC Norris Comprehensive Cancer Center and LAC+USC Medical Center will be recruited for this trial.
Who may be able to join
- Known or suspected breast cancer
- Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Ameria Casillas-Lopez, 323-865-0804, America.Casillas-Lopez@med.usc.edu
Julie Lang, M.D.
About this study
Official title: Core Biopsies of Breast Tumor Tissue Repository
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Breast Cancer
- Being tested
- cytology specimen collection procedure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
Also called cytologic sampling
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: cytology specimen collection procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program
Measured: 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
Measured: 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
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start14 Nov 2013
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Evanthia Roussos-Torres, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250352
- Sponsor's protocol ID
- 1B-13-2
- Other IDs
- NCI-2014-01932, HS-13-00342, 1B-13-2, P30CA014089
- Status last verified
- May 2026
- First submitted
- 23 Sep 2014
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Biopsies of Breast Tumor Tissue Repository
- ClinicalTrials.gov ID
- NCT02250352
- Acronym / sponsor ID
- 1B-13-2
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Nov 2013 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Nov 2027 (estimated)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort I (newly diagnosed, surgery before systemic therapy) | – | Other: cytology specimen collection procedurePatients 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) | – | Other: cytology specimen collection procedurePatients 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) | – | Other: cytology specimen collection procedurePatients 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) | – | Other: cytology specimen collection procedurePatients 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) | – | Other: cytology specimen collection procedurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects seen at USC Norris Comprehensive Cancer Center and LAC+USC Medical Center will be recruited for this trial.
Key inclusion criteria (2 listed)
- Known or suspected breast cancer
- Known or suspected metastatic solid tumor that originated in the breast per the patient's medical history
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytology specimen collection procedureAlso: cytologic samplingCorrelative studies | Other | 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) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evanthia Roussos-Torres, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeno Ashai (323-865-0463, zeno.ashai@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.