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Clinical Trial Protocol

VGH-TAYLOR: Comprehensive Precision Medicine Study Protocol on the Heterogeneity of Taiwanese Breast Cancer Patients

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Pages 4057-4069 | Received 28 Jan 2021, Accepted 05 Aug 2021, Published online: 19 Oct 2021
 

Abstract

Heterogeneity in breast cancer leads to diverse morphological features and different clinical outcomes. There are inherent differences in breast cancer between the populations in Asia and in western countries. The use of immune-based treatment in breast cancer is currently in the developmental stage. The VGH-TAYLOR study is designed to understand the genetic profiling of different subtypes of breast cancer in Taiwan and define the molecular risk factors for breast cancer recurrence. The T-cell receptor repertoire and the potential effects of immunotherapy in breast cancer subjects is evaluated. The favorable biomarkers for early detection of tumor recurrence, diagnosis and prognosis may provide clues for the selection of individualized treatment regimens and improvement in breast cancer therapy.

Lay abstract

We describe the rationale and design for the VGH-TAYLOR study, which includes Taiwanese patients with breast cancer and with a wide spectrum of clinical scenarios covering different breast cancer subtypes and clinical settings, such as the neoadjuvant, adjuvant and metastatic settings. The gene expression profile and genetic mutations of breast cancer subjects with the primary and recurrent tumors are compared. We also explore whether immune-related gene expression and diversity have any impact on response to treatment and survival. This study aims to discover biomarkers of detection of cancer relapse, diagnosis and prognosis that may enable personalized medicine and improvement in breast cancer treatment.

Clinical trial registration: NCT04626440 (ClinicalTrials.gov).

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/fon-2021-0131

Author contributions

Conceptualization, methodology, investigation, coordination and conception: LM Tseng and CY Liu. Acquisition of data and revising the work: CY Liu, CC Huang, YF Tsai, TC Chao, YS Lin, CJ Feng, YJ Chen, JH Chiu and CY Hsu. Drafting the article: CY Liu and JL Chen. Study coordinator: PJ Lien. All authors approval of the version to be published and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Acknowledgments

The authors are grateful to the patients at Taipei Veterans General Hospital, who provided contributions to enable this research project. Research was also supported by Biobank, Taipei Veterans General Hospital.

Financial & competing interests disclosure

This research is funded by Yong-Lin Healthcare Foundation (SINO-CANCER project) under the clinical study protocol no. QCR18002. The funding body's role was limited to funding with no influence on design, analysis and data interpretation and writing the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The whole study protocol was reviewed and approved by Institutional Review Board of Taipei Veterans General Hospital (2018-09-007A). Tumors for immunohistochemical study were collected in accordance with the Declaration of Helsinki and informed consents from sample donors were obtained at time of their donation.

Data availability

Taipei Veterans General Hospital retains the ownership of data, results, reports, findings, and discoveries related to this study. Yong-Lin Healthcare Foundation has the priority authorization. The patient data is unavailable to the public. The findings will be published in journals. The data might be available by requests which need to be approved by both institutions (Taipei Veterans General Hospital and Yong-Lin Healthcare Foundation).

Additional information

Funding

The authors are grateful to the patients at Taipei Veterans General Hospital, who provided contributions to enable this research project. Research was also supported by Biobank, Taipei Veterans General Hospital