Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
Sponsorvghtpe user
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female subjects aged over 20 years old
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
Disqualifiers
Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
Trial population
Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diagnostic stage or the Clinical outcome
Procedure/SurgeryAfter 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.
Treatment groups
1,875 Participants
are divided into 3 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Aug.20262
Clinical outcome
Breast cancer recurrence, overall survival and recurrence-free survival
Time frame
Aug.2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
vghtpe user
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Sponsor institution
YongLin Healthcare Foundation
Collaborator
Source ClinicalTrials.gov