NCT02063906

Brief Summary

Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

4.2 years

First QC Date

February 12, 2014

Last Update Submit

April 27, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    was measured from the first date of diagnosis of breast cancer to the date of death or the last follow-up visit

    1 year

Secondary Outcomes (1)

  • Recurrence-free survival

    1 Year

Study Arms (1)

Breast cancer stage I-III

who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received curative surgery for stage I-III breast cancer between January 2004 and September 2008 and had available immunohistochemistry profiles.

You may qualify if:

  • patients who received curative surgery
  • stage I-III breast cancer
  • between January 2004 and September 2008
  • had available immunohistochemistry profiles.

You may not qualify if:

  • age \<18 years old
  • microinvasive carcinoma of breast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Young-Hyuck Im, Pf

    Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Hyuck Im, MD, PhD

CONTACT

yh00.im@samsung.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2018

Study Completion

May 1, 2019

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

KR(1)