TME Neoadjuvant Breast Registry

Breast Cancer Clinical Trial

Official title:

TME Neoadjuvant Breast Registry (The NEAT Registry)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02596724
• Other study ID #: TMENEO-100
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 2, 2015
• Last updated: November 4, 2015
• Start date: July 2015
• Est. completion date: July 2022

Study information

• Verified date: November 2015
• Source: Targeted Medical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: July 2022
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Coordinated Health Breast Care Specialists	Allentown	Pennsylvania
United States	Dallas Surgical Group	Dallas	Texas
United States	Valley Medical Oncology Consultants	Los Gatos	California
United States	Nashville Breast Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic response and/or endocrine sensitivity		Post surgical treatment--usually within 4 months	No
Secondary	Metastasis-free/relapse-free survival in molecular subgroups		5 years	No