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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Invasive Breast Cancer

Intervention / Treatment
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* Other: Sampling of tumor tissue
* Other: Sampling of tumor tissue after breast cancer surgery
* Procedure: Sampling of tumor tissue after breast cancer surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br>Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery. | Other: Sampling of tumor tissue<br>* Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery<br>Other: Sampling of tumor tissue after breast cancer surgery<br>* Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery<br>Procedure: Sampling of tumor tissue after breast cancer surgery<br>* Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate in obtaining the Genomic Grade Index in clinical practice | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of Genomic Grade Index results on adjuvant treatment decision | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Feasibility, Genomic grade index