Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04626440
Other study ID # 2018-09-007A
Secondary ID QCR18002
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2018
Est. completion date August 31, 2026

Study information

Verified date November 2020
Source Taipei Veterans General Hospital, Taiwan
Contact Hsiang-Chung Tseng
Phone 886-2-55681176
Email chbc@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 1875
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
vghtpe user YongLin Healthcare Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Aug.2026
Primary Clinical outcome Breast cancer recurrence, overall survival and recurrence-free survival Aug.2026
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Active, not recruiting NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Enrolling by invitation NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05622240 - 99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer Early Phase 1
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2