Prospective Breast Cancer Biospecimen Collection

Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Invasive Breast Cancer; Carcinoma in Situ of the Breast
• Intervention / Treatment: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

Detailed Description

This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.

• Study Type: Observational
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Simone, MD; Phone Number: 215-955-6702; Email: Nicole.Simone@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Nicole Simone; Phone Number: 2159556702; Email: Nicole.Simone@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.

Description

Inclusion Criteria:

• Adults >18 years old at time of consent
• Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
• Patients with carcinoma in situ or invasive breast cancer

• Patient must be undergoing one of the following:

  • definitive surgical tumor resection for breast cancer OR
  • placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR
  • neurosurgical resection of a brain metastasis from primary breast cancer.

Exclusion Criteria:

• <18 years old
• Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
• Active drug/alcohol dependence or abuse history

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Newly Diagnosed Breast Cancer Patients; Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.	Procedure: Tissue Sample collection; Tissue sample collected following standard of care procedure patient was already scheduled to have; Other: Blood Sample Collection; A one time sample of blood will be collected on day of standard of care procedure; Other: Rectal Swab; optional rectal swab may be collected on day of standard of care procedure
Group 2: Patients with Brain Metastases from Primary Breast Cancer; The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow up will only consist of chart review to determine date of recurrence, metastases, and/or death.	Procedure: Tissue Sample collection; Tissue sample collected following standard of care procedure patient was already scheduled to have; Other: Blood Sample Collection; A one time sample of blood will be collected on day of standard of care procedure; Other: Rectal Swab; optional rectal swab may be collected on day of standard of care procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor biomarker identification	Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory-based breast cancer tumor genomic profile	Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.	Up to 5 years

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Nicole Simone, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Translational Research; Surgical Resection; Tumor Tissue Collection; Serum Collection; Plasma Collection; Fresh Tissue Collection; Fixed Tissue Collection; Biospecimen Collection; Vascular Access Placement
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Carcinoma; Carcinoma in Situ; Skin and Connective Tissue Diseases; Breast Carcinoma In Situ; Breast Neoplasms
• Other Study ID Numbers: 16D.674; JT 8877 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No