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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03772197
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
Amwise Diagnostics Pte. Ltd.

Brief Summary:
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.

Condition or disease
Breast Cancer Recurrence

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.

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Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03772197

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Taipei, Taiwan, 106
Sponsors and Collaborators
Amwise Diagnostics Pte. Ltd.
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Principal Investigator: Skye Cheng AMWISE DIAGNOSTICS PTE. LDT.
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Responsible Party: Amwise Diagnostics Pte. Ltd. Identifier: NCT03772197    
Other Study ID Numbers: RI-002
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amwise Diagnostics Pte. Ltd.:
Breast cancer
Distant recurrence
Gene-expression profiling
Locoreginal recurrence
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes