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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Recurrence

Keywords

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Breast cancer Distant recurrence NanoString Gene-expression profiling Prognosis Locoreginal recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Skye Cheng

Role: PRINCIPAL_INVESTIGATOR

AMWISE DIAGNOSTICS PTE. LDT.

Locations

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Amwise

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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RI-002

Identifier Type: -

Identifier Source: org_study_id