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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Breast Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 106
    • Amwise

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This study is a local validation and multi-center study. A total of 118 early-srage breast cancer (EBC) patients were included in this head-to-head comparison study, including 42, 15, and 81 patients treated between 2010 and 2016 at McKay Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center, and National Taiwan University Hospital, respectively, in Taiwan

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. T3-T4 or N2-N3
2. With distant metastasis before surgery
3. Preoperative chemotherapy / radiotherapy
4. Insufficient FFPE tumor samples

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The locoregional recurrence (LRR) rate, within 5 years after surgery.	LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk	5 years
The distant recurrence(DR) rate, within 5 years after surgery.	DR risk calculated by 18-GC of breast cancer patients would be classified into high risk	5 years

Collaborators and Investigators

• Sponsor: Amwise Diagnostics Pte. Ltd.
• Investigators: Principal Investigator: Skye Cheng, AMWISE DIAGNOSTICS PTE. LDT.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): October 18, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (ACTUAL): December 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Prognosis; Breast cancer; NanoString; Distant recurrence; Gene-expression profiling; Locoreginal recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: RI-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No