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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626440
• Other study ID #: 2018-09-007A
• Secondary ID: QCR18002
• Status: Recruiting
• Start date: November 22, 2018
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Hsiang-Chung Tseng
• Phone: 886-2-55681176
• Email: chbc[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study are: 1. To determine the difference in genetic profiling of subjects with breast cancer recurrence 2. To determine the comprehensive genetic profiling of subjects with late stage breast cancer 3. To determine the potential biomarkers for early detection and prognosis for breast cancer 4. 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: 1. Understanding the genetic profiling of different subtypes of breast cancer in Taiwan 2. Assessing the efficacy of different treatments in breast cancer subjects 3. Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence 4. Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects 5. Developing new strategies in treating patients with triple negative or late stage of breast cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1875
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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:

1. 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)];

2. 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Next Generation Sequencing (NGS)

Intervention

Procedure:
• Diagnostic stage or the Clinical outcome
After enrollment, individual subject will be assigned into one of the four groups according to the medical management received, the diagnostic stage of breast cancer (BC), or the clinical outcome of BC at enrollment.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
vghtpe user	YongLin Healthcare Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of genomic alteration	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	Aug.2026
Primary	Clinical outcome	Breast cancer recurrence, overall survival and recurrence-free survival	Aug.2026