Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
NCT ID: NCT04626440
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1875 participants
OBSERVATIONAL
2018-11-22
2026-08-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Group 1 \[(A) subjects who are planning to receive surgery (mastectomy or BCS) as the first-line treatment for BC and followed by adjuvant therapy, or (B) subjects with BC recurrence at screening, who had received surgery for primary BC within 3 years prior to screening, and with primary tumor FFPE tissues available\]
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
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 \[(A) stage IV subjects with BC recurrence beyond 3 years after surgery (mastectomy or BCS) or stage IV subjects who had received or are currently receiving treatments for BC\].
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
FEMALE
No
Sponsors
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YongLin Healthcare Foundation
UNKNOWN
vghtpe user
OTHER_GOV
Responsible Party
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vghtpe user
Chief of Comprehensive Breast Health Center, Department of Surgery
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Hsiang-Chung Tseng
Role: primary
References
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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.
Other Identifiers
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QCR18002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2018-09-007A
Identifier Type: -
Identifier Source: org_study_id