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Recruiting NCT04626440

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

— Observational Next Generation Sequencing (NGS) Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic stage or the Clinical outcome.
Who it may be relevant to
Registry conditions: Next Generation Sequencing (NGS), Breast Cancer. Basic parameters: from 20 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • The rate of genomic alteration [Time frame: Aug.2026]
  • Clinical outcome [Time frame: Aug.2026]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Taipei Veterans General Hospital — Taipei

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. PMID 34665002

Identifiers

NCT: NCT04626440 · 2018-09-007A · QCR18002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗