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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597179
• Other study ID #: 2012-08-065
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2015
• Last updated: April 27, 2017
• Start date: September 2012
• Est. completion date: July 2019

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Young-hyuck Im, MD, Ph.D
• Phone: 82-2-3410-3445
• Email: imyh00[@]skku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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