TME Neoadjuvant Breast Registry

Targeted Medical Education (TME)

Status: Unknown

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Other: Genomic and/or molecular testing of blood or tissue

Study type: Observational

Funder types: Other

Identifiers

NCT02596724

TMENEO-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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