Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer

NCT ID: NCT02597179

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metastatic Breast Cancer, Young Breast Cancer

Patients with feasible biopsy site.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. No feasible biopsy site
2. No written informed consent
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Hyuck Im

MD, Ph.D, Division of Hematology-Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Gangnam-Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young-hyuck Im, MD, Ph.D

Role: CONTACT

82-2-3410-3445

Facility Contacts

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Young-Hyuck Im, MD, Ph.D

Role: primary

82-2-3410-3445

Other Identifiers

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2012-08-065

Identifier Type: -

Identifier Source: org_study_id

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