TME RESEARCH

Neo-adjuvant Breast Registry Platform

Title 

TME Neo-adjuvant Breast Registry Trial Platform Linking Molecular-Genomic Profile Test Results and Treatment Response

Rationale

Neo-adjuvant therapy is increasingly being offered to patients with primary breast cancer; molecular genomic testing is part of the revolution in precision or personalized medicine.
What is the value of these tests in guiding selection and management of neo-adjuvant therapy?

Goal

Provide a platform to encourage private practice and academic physicians to collaborate in gathering information that will help identify effective neo-adjuvant breast treatment protocols and/or clinical trials based on the patient’s individual biomarkers.

This Phase IV registry is designed to capture impact and outcomes of new comprehensive molecular tumor assays, specifically correlating molecular analysis with response to specific treatments and to response in general. Further, the registry assesses changes in decision-making when oncologists have access to comprehensive molecular analysis of patient's tumor.  

Description

This prospective observational registry links molecular genomic testing to treatment response and surrogate survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy

Scope

  • All patients who are selected for neo-adjuvant therapy and who have had genomic molecular testing will be included
  • Approximately 50 institutions in the US will be invited to contribute patient data 
  • Up to 1000 patients will be enrolled over 4 years
  • Data will be captured electronically for ease of data entry and access
  • Scientific Advisory board oversight
  • IRB approval from E&I IRB Services, Corte Madera, CA or via local institution.
  • Study is in progress

Why should I participate?

  • Help define standard of care and best practices in use of molecular genomic testing and neo-adjuvant therapy
  • Ready access to practice data for insight, quality control, publication and community presentations
  • Ready access to data  to support reimbursement of testing and therapy
  • Participate in multi-institution publications

Sponsorship

Funded initially via a research grant from TME and Paradigm (http://www.paradigmdx.org)

For additional information, contact:

Pat Whitworth
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TME Research
Mary Kay Hardwick
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Project details

Tags: NeoAdjuvant Breast Registry Platform

 

What is TME Research?

TME Research is an extension of the TME mission to improve quality and access to emerging technologies and best practices in breast cancer prevention, diagnosis, treatment and patient care.

We are a partnership of community leading practitioners and experienced researchers who design, execute and drive enrollment in Registries that collect the real world experience and data that support the adoption of emerging technologies.
Extensive experience in publication helps us turn raw data into insight, analysis, publications and presentation.

TME Research registries provide an opportunity for research partnerships with industry.

 

Introducing a significant investment in turnkey registries

These Registries target areas of significant interest in breast cancer with the aim of supporting development, understanding and adoption of emerging technologies.  Jointly funded by TME and industry.

 

 

Why should you participate in one of our registries?



  • Help define standard of care and best practices
  • Ready access to individual practice data for insight, quality control, publication and community presentations
  • Gain insight into how other practices are utilizing new technologies and with what success
  • Access to data to support utilization and reimbursement
  • Participate in multi-institution publications
Can I really implement a research Registry in my practice?

TME designs the Registry, creates the electronic tools for collecting and providing you access to the data, and trains and supports implementation in your practice.