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

Comprehensive Precision Medicine 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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Next Generation Sequencing (NGS)
• Intervention / Treatment: Procedure: Diagnostic stage or the Clinical outcome

• Study Type: Observational
• Enrollment (Anticipated): 1875

Contacts and Locations

• Study Contact: Name: Hsiang-Chung Tseng; Phone Number: 886-2-55681176; Email: chbc@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Hsiang-Chung Tseng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Group 1 [(A) subjects who are planning to receive surgery (mastectomy or BCS) as the first-line treatment for BC and followed by adjuvant therapy, or (B) subjects with BC recurrence at screening, who had received surgery for primary BC within 3 years prior to screening, and with primary tumor FFPE tissues available]	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.
Group 2; subjects who are planning to receive neoadjuvant therapy as the first-line treatment for BC and followed by surgery	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.
Group 3; Group 3-1 (subjects diagnosed with de novo and treatment naïve stage IV BC); or Group 3-2 [(A) stage IV subjects with BC recurrence beyond 3 years after surgery (mastectomy or BCS) or stage IV subjects who had received or are currently receiving treatments for BC].	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical outcome	Breast cancer recurrence, overall survival and recurrence-free survival	Aug.2026

Collaborators and Investigators

• Sponsor: vghtpe user
• Collaborators: YongLin Healthcare Foundation

Publications and helpful links

General Publications

• Liu CY, Huang CC, Tsai YF, Chao TC, Lien PJ, Lin YS, Feng CJ, Chen JL, Chen YJ, Chiu JH, Hsu CY, Tseng LM. VGH-TAYLOR: Comprehensive precision medicine study protocol on the heterogeneity of Taiwanese breast cancer patients. Future Oncol. 2021 Oct 19. doi: 10.2217/fon-2021-0131. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2018
• Primary Completion (ANTICIPATED): August 31, 2026
• Study Completion (ANTICIPATED): August 31, 2026

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2018-09-007A; QCR18002 (OTHER_GRANT: YongLin Healthcare Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No