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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genomic and/or molecular testing of blood or tissue | Other | Genomic and/or molecular testing of blood or tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response and/or endocrine sensitivity | Post surgical treatment--usually within 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis-free/relapse-free survival in molecular subgroups | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.
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| Name | Affiliation | Role |
|---|---|---|
| Pat Whitworth, M.D. | Nashville Breast Center | Principal Investigator |
| Peter Beitsch, M.D. | Dallas Surgical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Medical Oncology Consultants | Los Gatos | California | 95032 | United States | ||
| Coordinated Health Breast Care Specialists |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Allentown |
| Pennsylvania |
| 18104 |
| United States |
| Nashville Breast Center | Nashville | Tennessee | 37203 | United States |
| Dallas Surgical Group | Dallas | Texas | 75231 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |