NCT02597179

Brief Summary

The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

5.8 years

First QC Date

October 29, 2015

Last Update Submit

April 27, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome.

    1 year

Study Arms (1)

Metastatic Breast Cancer, Young Breast Cancer

Patients with feasible biopsy site.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Histologically or cytologically conrfirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age) with feasible biopsy site.

You may qualify if:

  • Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
  • HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
  • Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
  • Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
  • Age ≥ 21 years
  • Written informed consent

You may not qualify if:

  • No feasible biopsy site
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-Gu, 135-710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tumor samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Young-hyuck Im, MD, Ph.D

CONTACT

82-2-3410-3445imyh00@skku.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D, Division of Hematology-Oncology

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 5, 2015

Study Start

September 1, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

KR(1)