TME Neoadjuvant Breast Registry
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | July 2022 |
TME Neoadjuvant Breast Registry (The NEAT Registry)
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.
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.
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.
Inclusion Criteria:
- Patients with histologically proven invasive breast cancer who have started or are
scheduled to start neo-adjuvant chemotherapy or endocrine therapy
- Ages 18-90
- Written informed consent
Exclusion Criteria:
- Patients who have had excisional biopsy or axillary dissection
- Patients with confirmed metastatic disease
- Patients who have had recent chemotherapy
We found this trial at
4
sites
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