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

F

Free University of Brussels (ULB)

Status

Completed

Conditions

Invasive Breast Cancer

Treatments

Other: Sampling of tumor tissue
Procedure: Sampling of tumor tissue after breast cancer surgery

Study type

Observational

Funder types

Other

Identifiers

NCT01916837
2009-015521-36 (EudraCT Number)
1668

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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