Clinical trial NCT03772197: Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Recurrence
Keywords: Breast cancer
Distant recurrence
NanoString
Gene-expression profiling
Prognosis
Locoreginal recurrence
Lead sponsor: Amwise Diagnostics Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The locoregional recurrence (LRR) rate, within 5 years after surgery.
timeFrame: 5 years
measure: The distant recurrence(DR) rate, within 5 years after surgery.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Amwise
Study officials:
affiliation: AMWISE DIAGNOSTICS PTE. LDT.
name: Skye Cheng
role: PRINCIPAL_INVESTIGATOR
References: