Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.
Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded. Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website. All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.
Study Type
OBSERVATIONAL
Enrollment
1,000
Genomic and/or molecular testing of blood or tissue
Valley Medical Oncology Consultants
Los Gatos, California, United States
Coordinated Health Breast Care Specialists
Allentown, Pennsylvania, United States
Nashville Breast Center
Nashville, Tennessee, United States
Dallas Surgical Group
Dallas, Texas, United States
Pathologic response and/or endocrine sensitivity
Time frame: Post surgical treatment--usually within 4 months
Metastasis-free/relapse-free survival in molecular subgroups
Time frame: 5 years
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