Understanding genetic differences in Taiwanese breast cancer patients using advanced sequencing techniques
Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
This study is trying to understand the genetic differences in Taiwanese women with breast cancer to find new ways to detect and treat the disease, especially for those with advanced stages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1875 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04626440 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the genetic profiles of Taiwanese women with breast cancer, focusing on those with recurrence and late-stage disease. By utilizing next-generation sequencing (NGS) tools, the study will identify potential biomarkers for early detection and prognosis, as well as assess the immune system's role in various breast cancer subtypes. The findings could enhance treatment strategies, particularly for triple-negative and late-stage breast cancer patients. The study will involve collecting and analyzing genetic data from participants to better understand the disease's heterogeneity.
Who should consider this trial
Good fit: Ideal candidates include female patients over 20 years old with a confirmed diagnosis of primary invasive breast cancer who are planning to receive treatment.
Not a fit: Patients with breast cancer who do not have available primary tumor FFPE tissues or do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and personalized treatment strategies for breast cancer patients.
How similar studies have performed: Other studies utilizing next-generation sequencing for breast cancer have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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: 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
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hsiang-Chung Tseng
- Email: chbc@vghtpe.gov.tw
- Phone: 886-2-55681176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.