TME Neoadjuvant Breast Registry

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02596724
Study type	Observational [Patient Registry]
Source	Targeted Medical Education
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	July 2015
Completion date	July 2022

View Details

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