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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04626440
Other study ID # 2018-09-007A
Secondary ID QCR18002
Status Recruiting
First received
Last updated
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
Is FDA regulated No
Health authority
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

Study Design


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.


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



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
Primary Clinical outcome Breast cancer recurrence, overall survival and recurrence-free survival Aug.2026
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