NCT03772197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

December 10, 2018

Last Update Submit

December 16, 2018

Conditions

Breast CancerRecurrence

Keywords

Breast cancerDistant recurrenceNanoStringGene-expression profilingPrognosisLocoreginal recurrence

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amwise

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Skye Cheng

    AMWISE DIAGNOSTICS PTE. LDT.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 11, 2018

Study Start

June 1, 2018

Primary Completion

October 18, 2018

Study Completion

November 1, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

TW(1)