2015-01-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/659538摘要：過去，我們已進行並完成一些研究者自行發起之國內多中心乳癌臨床試驗案。以先 前的合作基礎，我們聯合國內十家醫學中心，包括台大醫院，台北榮總，三軍總醫院， 馬偕醫院，林口長庚醫院，台中榮總，彰化基督教醫院，高醫附設醫院，高雄榮總，以 及和信治癌醫院，建立了乳癌臨床試驗資源中心。此資源中心建立了乳癌臨床試驗平 台，及臨床檢體，臨床資料收集之平台。此平台之建立將有利於創造出更多高水準之本 土多中心臨床試驗，爭取國際藥廠與我國合作。此平台之建立亦將有助於支持台灣本土 藥廠或研究機構所開發之新藥開發研究在最後一關臨床試驗。關於乳癌臨床資料的收集 及檢題的收集更有助於台灣各項的重要的學術研究的發展資源。成立此資源中心之後，我們完成了，並將持續進行下列重要的工作；1)我們建立了 臨床檢體，臨床資料收集之平台。據此，我們將開始進行兩項回溯性臨床研究，著重於 原位癌的治療策略，以及三陰性乳癌者治療法則。2)我們完成了一項針對乳癌腦轉移全 腦放射治療後復發的病人新穎的藥物治療的學者自行發起之臨床試驗。此研究結果獲致 世界最佳之療效成績，將成為未來的標準治療。我們持續進行兩項學者自行發起之臨床 試驗，預計明年將完成收案。3)我們發展了三個新的學者自行發起之臨床試驗，其中一 個獲得藥廠的全力支持，升級成為多國多中心之全球性臨床試驗，仍由我們擔任主席。 此外，我們正在設計臺灣多中心第三期臨床試驗，比較經保留手術切除之低或中惡性度 原位乳管癌是否接受放射治療，去研究這兩組間之乳房局部復發狀況，並藉由分子研究 之幫忙，進一步發展臺灣女性原位乳管癌之最佳治療。預計明年開始收案。4)我們持續 協助主持執行國內藥廠委託之新藥臨床試驗，該臨床試驗為國際性，目標將是推動新藥 獲得包括美國食品藥物管理局的許可證。5)我們執行了許多項藥廠主導之國際性臨床 試驗，並持續協助引進這類國際性臨床試驗。我們相信，此資源中心的成功將對我國在乳癌臨床試驗領域的國際地位有重要的提升。<br> Abstract: We have organized a Taiwan Clinical Trial Consortium - Breast Cancer (TCTC-BC), in order to provide technical and consultation platforms for further improve the productivity of this network. At beginning, this consortium involved 10 medical centers, including: National Taiwan University Hospital, Taipei Veteran General Hospital, Taichung Veteran General Hospital, Kaohsiung Veteran General Hospital, Changhua Christian Hospital, Mackay Memorial Hospital, Chang-Gung Memorial Hospital, Tri-Service General Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, and Koo Fundation Su Yat-Sen Cancer Center. By establishing this joint research group, we could perform high quality, well coordinated clinical trials on new anti-breast cancer drugs in Taiwan. We will also collaborate with many multinational pharmaceutical and biotechnology companies, as well as research institutions, in oncology clinical trials for breast cancer.Specific aims of this consortium are:1.To set up the “Taiwan Breast Cancer Consortium” as an excellent consortium of breast cancer clinical trial in Asia.2.To attract international pharmaceutical companies to perform their breast cancer trials in Taiwan.3.To help domestic pharmaceutical companies conduct their breast cancer trials in Taiwan.4.To help investigators of the consortium conduct investigator-initiated trials for breast cancer.In the past two years and for the next year, we have following achievements and planning: 1.) we have set up Web-based data collection system under TBCC construction. Base on this system, we will start two important retrospective study focuses on the treatment strategy in ductal carcinoma in situ, and treatment in triple negative breast cancer. 2.) We have complete one Pi-initiated trial focus on the treatment for breast cancer with brain metastases progressing from whole brain radiotherapy. The result is outstanding and the treatment will surely be the future standard in this indication. We also continue two other Pi-initiated trials, which are expected to be completed next year. 3.) We developed three new multi-center clinical trials. One of them has been upgraded by the international pharmaceutical company to become a global study, but still chaired by us. Also, we are designing a multi-center randomized trial to compare breast conserving treatment (BCS) with and without radiotherapy for low and intermediate-risk of breast ductal carcinoma in situ (DCIS) accompanied by biomarkers study in Taiwan to investigate the local recurrence event and thus develop a new treatment strategy for Taiwanese breast DCIS. This trial will start recruitment in Jan 2015. 4.) We continue to help domestic pharmaceutical companies conduct their breast cancer trials in Taiwan. 5.) We have conduct many pharmaceutical company sponsored international trials, and continue to intermediate service for new drug clinical trial sponsored by international pharmaceutical company to Taiwan.We believe success of this consortium is important in the future competition with other Asian countries in breast cancer clinical trial business.