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Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools

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ClinicalTrials.gov Identifier: NCT04626440
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
YongLin Healthcare Foundation
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Study Description
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Brief 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

Condition or disease Intervention/treatment
Next Generation Sequencing (NGS) Breast Cancer Procedure: Diagnostic stage or the Clinical outcome

Study Design
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Study Type : Observational
Estimated Enrollment : 1875 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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]
 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.
Group 2
subjects who are planning to receive neoadjuvant therapy as the first-line treatment for BC and followed by surgery
 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.
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].
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. Clinical outcome [ Time Frame: Aug.2026 ]
    Breast cancer recurrence, overall survival and recurrence-free survival


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626440


Contacts
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Contact: Hsiang-Chung Tseng 886-2-55681176 chbc@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Hsiang-Chung Tseng         
Principal Investigator: Ling-Ming Tseng, MD         
Sponsors and Collaborators
vghtpe user
YongLin Healthcare Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: vghtpe user, Chief of Comprehensive Breast Health Center, Department of Surgery, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04626440    
Other Study ID Numbers: 2018-09-007A
QCR18002 ( Other Grant/Funding Number: YongLin Healthcare Foundation )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases