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Lay Description

This is a prospective, observational study designed to evaluate the clinical validity of Myriad Genetics’ MRD test in patients diagnosed with breast cancer. It is expected that enrollment will be split between the different breast cancer subtypes defined by immunohistochemistry (HR+/HER2-, HER2+ (HR+ and HR-), TNBC) and according to BINV-A of National Comprehensive Cancer Network guidelines with ER+ status used here as >10% of nuclei staining.

Category

  • Cancers and Other Neoplasms
  • Genetics
IRB Number
STUDY00000011
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
-
Eligible Genders
all
Accepts Healthy Volunteers

Inclusion Criteria

  • Age 18 years or older or age of majority in state of residence
  • A first diagnosis of invasive breast cancer
  • Planning to undergo surgical treatment for curative intent
  • Planning to undergo regular follow-up and standard-of-care recurrence monitoring
  • T1-4
  • ER/PR/HER2 status known
  • If (HR+/HER2-), patient must be eligible for chemotherapy

Exclusion Criteria

  • Metastatic disease or currently active additional cancer diagnosis (except non-melanoma skin cancer or a secondary breast cancer at the time of diagnosis)
  • Previous allogeneic organ or tissue transplant

Study Design

Study Contact

Regulatory Point of Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Principal Investigator
Marcela Mazo Canola