TME Neoadjuvant Breast Registry
1 other identifier
observational
1,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedNovember 5, 2015
November 1, 2015
3 years
November 2, 2015
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic response and/or endocrine sensitivity
Post surgical treatment--usually within 4 months
Secondary Outcomes (1)
Metastasis-free/relapse-free survival in molecular subgroups
5 years
Interventions
Genomic and/or molecular testing of blood or tissue
Eligibility Criteria
Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.
You may qualify if:
- 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
You may not qualify if:
- Patients who have had excisional biopsy or axillary dissection
- Patients with confirmed metastatic disease
- Patients who have had recent chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Valley Medical Oncology Consultants
Los Gatos, California, 95032, United States
Coordinated Health Breast Care Specialists
Allentown, Pennsylvania, 18104, United States
Nashville Breast Center
Nashville, Tennessee, 37203, United States
Dallas Surgical Group
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pat Whitworth, M.D.
Nashville Breast Center
- PRINCIPAL INVESTIGATOR
Peter Beitsch, M.D.
Dallas Surgical Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 4, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2022
Last Updated
November 5, 2015
Record last verified: 2015-11