Status:

COMPLETED

Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer

Lead Sponsor:

Jules Bordet Institute

Conditions:

Invasive Breast Cancer

Eligibility:

All Genders

18+ years

Brief Summary

In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment rec...

Detailed Description

The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 no...

Eligibility Criteria

Inclusion

  • Histologically confirmed invasive breast cancer meeting the following criteria:
  • T1, T2, or operable T3 disease
  • Zero to three positive lymph nodes and no distant metastases
  • Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance

Exclusion

  • No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study

Key Trial Info

Start Date :

February 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT01916837

Start Date

February 1 2010

End Date

December 1 2010

Last Update

August 6 2013

Active Locations (1)

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Institut Jules Bordet

Brussels, Belgium, 1000