Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools

vghtpe user1 site in 1 country1,875 target enrollmentNovember 22, 2018

ConditionsNext Generation Sequencing (NGS)Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Next Generation Sequencing (NGS)
Sponsor: vghtpe user
Enrollment: 1875
Locations: 1
Primary Endpoint: The rate of genomic alteration
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are:

To determine the difference in genetic profiling of subjects with breast cancer recurrence
To determine the comprehensive genetic profiling of subjects with late stage breast cancer
To determine the potential biomarkers for early detection and prognosis for breast cancer
To determine the genetic profiling of immune system in different subtypes of breast cancer

By integrating and analyzing the data generated using the methods of NGS, these information can be used for:

Understanding the genetic profiling of different subtypes of breast cancer in Taiwan
Assessing the efficacy of different treatments in breast cancer subjects
Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence
Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects
Developing new strategies in treating patients with triple negative or late stage of breast cancer

Registry

clinicaltrials.gov

Start Date

November 22, 2018

End Date

August 31, 2026

Last Updated

5 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

vghtpe user

Responsible Party

Sponsor Investigator

Principal Investigator

vghtpe user

Chief of Comprehensive Breast Health Center, Department of Surgery

Taipei Veterans General Hospital, Taiwan

Eligibility Criteria

Inclusion Criteria

•Female subjects aged over 20 years old
•Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer. However, subjects with breast cancer recurrence at screening will be enrolled if meet both the following conditions:
•Subjects had received surgery for primary breast cancer within 3 years prior to screening \[i.e. recurrence within 3 years after surgery (mastectomy or BCS)\];
•Subjects diagnosed with stage IV breast cancer beyond 3 years after surgery (mastectomy or BCS) or who had received or are currently receiving treatments for breast cancer. And subjects with primary tumor FFPE tissues available and pass the RNA quality check.
•Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 3
•Life expectancy ≥ 3 months
•Subject agrees to provide the written informed consent. If a subject has breast cancer recurrence within 3 years prior to screening, she will be eligible if she agrees to provide the paired FFPE tissues (primary and recurrent tumors)

Exclusion Criteria

•Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening

Outcomes

Primary Outcomes

The rate of genomic alteration

Time Frame: Aug.2026

Discovery of comprehensive genetic profiles including copy number variation and single nucleotide polymorphism in group 1, 2 and 3 subjects. Discovery of genetic mutations of T cell receptor

Clinical outcome

Time Frame: Aug.2026

Breast cancer recurrence, overall survival and recurrence-free survival