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

Invasive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916837
• Other study ID #: 1668
• Secondary ID: 2009-015521-36
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: August 2, 2013
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2013
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Intervention

Other:
• Sampling of tumor tissue
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
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery

Procedure:
• Sampling of tumor tissue after breast cancer surgery
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The success rate of reporting Genomic Grade Index results	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).	12 months	No
Primary	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	No
Secondary	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	No