Core Biopsies for Establishing a Breast Tumor Tissue Repository

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: cytology specimen collection procedure

• Registration Number: NCT02250352
• Lead Sponsor: University of Southern California

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.

Detailed Description

PRIMARY OBJECTIVES:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11-14
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-11-14
• Study Completion: 2025-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1450

Inclusion Criteria

• Known or suspected breast cancer

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort I (newly diagnosed, surgery before systemic therapy)	cytology specimen collection procedure	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 III (patients with suspicious breast mass)	cytology specimen collection procedure	Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. 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)	cytology specimen collection procedure	Patients undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients may also undergo 1-3 extra core biopsies.
Cohort II (newly diagnosed, systemic therapy before surgery)	cytology specimen collection procedure	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.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States