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

Completed

• Conditions: Invasive Breast Cancer
• Interventions: Other: Sampling of tumor tissue; Procedure: Sampling of tumor tissue after breast cancer surgery

• Registration Number: NCT01916837
• Lead Sponsor: Jules Bordet Institute

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 recommendations.

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

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2013-07-30
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Study First Posted: 2013-08-06
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Sampling of tumor tissue	Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery.
Single arm	Sampling of tumor tissue after breast cancer surgery	Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery.

Primary Outcome Measures

Name	Time	Method
The success rate in obtaining the Genomic Grade Index in clinical practice	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 Outcome Measures

Name	Time	Method
The impact of Genomic Grade Index results on adjuvant treatment decision	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.

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium