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OpenTrials
Completed

NCT Number: NCT03772197

Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)

A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Amwise

Taipei, 106, Taiwan

About this study

With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients may suffer from side effects without receiving the full benefits of adjuvant therapies.

To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed

In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading).

By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017.
  • Surgery (mastectomy or breast preservation) as the first treatment.
  • ER or PR IHC positive
  • HER2 negative
  • N0-N1 patient
  • Available with FFPE tumor tissue

Exclusion criteria

  • T3-T4 or N2-N3
  • With distant metastasis before surgery
  • Preoperative chemotherapy / radiotherapy
  • Insufficient FFPE tumor samples

Treatment and study plan

Primary outcomes

  1. The locoregional recurrence (LRR) rate, within 5 years after surgery.

    Time frame: 5 years

    LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk

  2. The distant recurrence(DR) rate, within 5 years after surgery.

    Time frame: 5 years

    DR risk calculated by 18-GC of breast cancer patients would be classified into high risk

Sponsors and collaborators

Lead sponsor

Amwise Diagnostics Pte. Ltd.

Industry

Registry information

Official study title

Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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