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

NCT04626440 | Recruiting DMC

• 2 other identifiers: 2018-09-007AQCR18002
• Study Type: observational
• Target: 1,875
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

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

Conditions

Next Generation Sequencing (NGS); Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

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

Interventions

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• vghtpe user: lead
• YongLin Healthcare Foundation: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 34665002 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hsiang-Chung Tseng

CONTACT

886-2-55681176; chbc@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Comprehensive Breast Health Center, Department of Surgery

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 12, 2020
• Study Start: November 22, 2018
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)