Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04626440

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Hsiang-Chung Tseng

CONTACT

Ling-Ming Tseng, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic stage or the Clinical outcome

Procedure

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.

Primary outcomes

  1. 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

  2. Clinical outcome

    Time frame: Aug.2026

    Breast cancer recurrence, overall survival and recurrence-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiang-Chung Tseng

CONTACT

[email protected]

886-2-55681176

Sponsors and collaborators

Lead sponsor

vghtpe user

Other Gov

Collaborators

  • YongLin Healthcare Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.