Prospective Breast Cancer Biospecimen Collection

Thomas Jefferson University

Status: Enrolling

Conditions: Breast Cancer; Carcinoma in Situ of the Breast; Invasive Breast Cancer

Treatments: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

Study type: Observational

Funder types: Other

Identifiers

NCT04074720

16D.674

JT 8877 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Group 1: Newly Diagnosed Breast Cancer Patients

Description:

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.

Treatment:

Other: Rectal Swab

Other: Blood Sample Collection

Procedure: Tissue Sample collection

Group 2: Patients with Brain Metastases from Primary Breast Cancer

Description:

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.

Treatment:

Other: Rectal Swab

Other: Blood Sample Collection

Procedure: Tissue Sample collection