Next Generation Sequencing (NGS)NCT04626440
Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
An observational study of Next Generation Sequencing (NGS) and Breast Cancer, run by vghtpe user at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Next Generation Sequencing (NGS), Breast Cancer
- What is being tested?
- Diagnostic stage or the Clinical outcome
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,875 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Nov 2018to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer.
Who may be able to join
- 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)
Who cannot join
- Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Hsiang-Chung Tseng
Ling-Ming Tseng, MD
About this study
Official title: Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
The objectives of this study are:
- To determine the difference in genetic profiling of subjects with breast cancer recurrence
- To determine the comprehensive genetic profiling of subjects with late stage breast cancer
- To determine the potential biomarkers for early detection and prognosis for breast cancer
- To determine the genetic profiling of immune system in different subtypes of breast cancer
Read more
By integrating and analyzing the data generated using the methods of NGS, these information can be used for:
- Understanding the genetic profiling of different subtypes of breast cancer in Taiwan
- Assessing the efficacy of different treatments in breast cancer subjects
- Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence
- Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects
- Developing new strategies in treating patients with triple negative or late stage of breast cancer
- Conditions
- Next Generation Sequencing (NGS), Breast Cancer
- Being tested
- Diagnostic stage or the Clinical outcome
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic stage or the Clinical outcomeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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 Receives: 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]. Receives: Procedure: Diagnostic stage or the Clinical outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Aug.2026
Clinical outcome
Breast cancer recurrence, overall survival and recurrence-free survival
Measured: Aug.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start22 Nov 2018
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Next Generation Sequencing (NGS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- vghtpe user
- Sponsor type
- Other government
- Collaborators
- YongLin Healthcare Foundation
- Responsible party
- Sponsor-investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626440
- Sponsor's protocol ID
- 2018-09-007A
- Other IDs
- QCR18002
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34665002
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
- ClinicalTrials.gov ID
- NCT04626440
- Acronym / sponsor ID
- 2018-09-007A
- Conditions
- Next Generation Sequencing (NGS), Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,875 participants (estimated)
- Lead sponsor
- vghtpe userOther government
- Collaborators
- YongLin Healthcare Foundation
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- To determine the difference in genetic profiling of subjects with breast cancer recurrence
- To determine the comprehensive genetic profiling of subjects with late stage breast cancer
- To determine the potential biomarkers for early detection and prognosis for breast cancer
- 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:
- Understanding the genetic profiling of different subtypes of breast cancer in Taiwan
- Assessing the efficacy of different treatments in breast cancer subjects
- Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence
- Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects
- Developing new strategies in treating patients with triple negative or late stage of breast cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Diagnostic stage or the Clinical outcomeGroup 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] |
| Group 2 | – | Procedure: Diagnostic stage or the Clinical outcomesubjects who are planning to receive neoadjuvant therapy as the first-line treatment for BC and followed by surgery |
| Group 3 | – | Procedure: Diagnostic stage or the Clinical outcomeGroup 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]. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer.
Key inclusion criteria (7 listed)
- 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:
- 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)
Key exclusion criteria (1 listed)
- Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic stage or the Clinical outcomeAfter 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. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
The rate of genomic alteration
Time frame: Aug.2026
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
Clinical outcome
Time frame: Aug.2026
Breast cancer recurrence, overall survival and recurrence-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 34665002Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Next Generation Sequencing (NGS) and Breast Cancer, run by vghtpe user at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiang-Chung Tseng (886-2-55681176, chbc@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of genomic alteration (time frame: Aug.2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.