Genome Sequencing in Refractory Breast Cancer to Molecula... | NCT02597179

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

NCT02597179

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

May 1, 2017Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Nov 4, 2015

First Posted Date

Nov 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2017

Last Update Posted Date

May 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young-Hyuck Im, MD, Ph.D, Division of Hematology-Oncology, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metastatic Breast Cancer, Young Breast Cancer		Patients with feasible biopsy site.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No feasible biopsy site
No written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young-hyuck Im, MD, Ph.D	Contact	82-2-3410-3445		imyh00@skku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Gangnam-Gu	135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided