TME Neoadjuvant Breast Registry

• Conditions: Breast Neoplasms; Breast Cancer

• Registration Number: NCT02596724
• Lead Sponsor: Targeted Medical Education

Brief 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.

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 Timeline

• Study Start: 2015-07
• Status Verified: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05
• Primary Completion: 2018-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic response and/or endocrine sensitivity	Post surgical treatment--usually within 4 months

Secondary Outcome Measures

Name	Time	Method
Metastasis-free/relapse-free survival in molecular subgroups	5 years

Trial Locations

Locations (4)

Dallas Surgical Group; 🇺🇸 Dallas, Texas, United States

Coordinated Health Breast Care Specialists; 🇺🇸 Allentown, Pennsylvania, United States

Nashville Breast Center; 🇺🇸 Nashville, Tennessee, United States

Valley Medical Oncology Consultants; 🇺🇸 Los Gatos, California, United States