Invasive Breast Cancer
Conditions
Keywords
Breast cancer, Feasibility, Genomic grade index
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.
Interventions
OTHERSampling of tumor tissue
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
OTHERSampling 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
Sponsors
Jules Bordet Institute
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The success rate of reporting Genomic Grade Index results | 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). |
Countries
Belgium
Outcome results
None listed