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Completed

NCT Number: NCT01916837

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

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 recommendations.

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Key information

Conditions

Invasive Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Jules Bordet

Brussels, 1000, Belgium

About this study

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 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in > 70% of evaluated patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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

Treatment and study plan

Sampling of tumor tissue

Other

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery

Sampling of tumor tissue after breast cancer surgery

Other

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery

Sampling of tumor tissue after breast cancer surgery

Procedure

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery

Primary outcomes

  1. The success rate in obtaining the Genomic Grade Index in clinical practice

    Time frame: 12 months

    To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer

Secondary outcomes

  1. The impact of Genomic Grade Index results on adjuvant treatment decision

    Time frame: 12 months

    The secondary objective was to evaluate the impact of Genomic Grade Index on adjuvant treatment decisions for patients with early breast cancer. This was done by comparing physicians' treatment recommendations before having knowledge of the GGI test results to recommendations with a hypothetical GG-1 and GG-3 result and to the treatment ultimately administered after discussion with the patient.

Other outcomes

  1. The success rate of reporting Genomic Grade Index results

    Time frame: 12 months

    To test the success rate of reporting GGI, a minimum sample size of 137 was calculated to have a power of 90% at a one-sided significance level of 5% using an empirical estimate of variance (null hypothesis H0: p ≤ 0.70 vs. alternative hypothesis HA: p ≥ 0.80).

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2013
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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