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NBRST: Prospective Neo-adjuvant REGISTRY Trial

NCT01479101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1142

Last updated 2021-01-19

No results posted yet for this study

Summary

The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.

Conditions

Interventions

OTHER

MammaPrint 70-gene expression profile

OTHER

BluePrint 80 gene expression profile

Sponsors & Collaborators

  • Agendia

    lead INDUSTRY

Principal Investigators

  • Pat Whitworth, MD · Nashville Breast Center

  • Stephanie Akbari, MD · Reinsch Pierce Family Center for Breast Health

  • Mark Gittleman, MD · Breast Care Specialists

  • Peter Beitsch, MD · Dallas Surgical Group

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-01-31
Completion
2021-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479101 on ClinicalTrials.gov