TME Neoadjuvant Breast Registry

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Other: Genomic and/or molecular testing of blood or tissue

Detailed 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Los Gatos, California, United States, 95032
      • Valley Medical Oncology Consultants
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Coordinated Health Breast Care Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Breast Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Surgical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathologic response and/or endocrine sensitivity	Post surgical treatment--usually within 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Metastasis-free/relapse-free survival in molecular subgroups	5 years

Collaborators and Investigators

• Sponsor: Targeted Medical Education
• Investigators: Principal Investigator: Pat Whitworth, M.D., Nashville Breast Center; Principal Investigator: Peter Beitsch, M.D., Dallas Surgical Group

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer; Neoadjuvant therapy for breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TMENEO-100