Current Activities

  1. To establish the consortium – To sign a memorandum and agree on collaborations among key investigators of different sites in Taiwan  
  2. To achieve uniform quality among centers –
    • To run general or protocol-specific training for primary investigators, study coordinators and nurses Opt-822/821 PI meeting and study nurse training in May (trial sponsored by Optimer, a Taiwanese biotech company)
    • To do site monitoring (PI-initiated trial) or evaluation (feedback from CRO and sponsors)
    • Site monitoring for TaiNac trial, LOVE trial, BEEP trial
  3. To have precise enrollment –  build up database or patient registry of potential trial subjects general form suggested by Dr. Ou-Yang, getting approval from all PIs-
    • To assigns dedicated study coordinator for networking with hospitals outside consortium one each at MMGH, Taichung VGH, KMUH
    • To collect information of conducted trials and accrual records of participating investigators

 Current IIT or Clinical Studies Under TLC

  1. An open label, randomized phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-verexpressing breast cancer failing one prior trastuzumab treatment.
  2. A randomized multicenter, double-blind, place-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
  3. A double-blind, randomized trial of active immunotherapy with globo h-KLH (OPT-822) in subjects with metastatic breast cancer.
  4. A phase II randomized study of pegylated liposomal doxorubicin (Lipo-Dox)-Cyclophosphamide versus Epirubicin-Cyclophosphamide as adjuvant chemotherapy in HER2-negative stage I and II breast cancer patients.
  5. A randomized phase III study of docetaxel/epirubicin versus tailored regimens as neoadjuvant chemotherapy for stage II/III breast cancer with tumor size more than 3 cm
  6. A randomised, multicentre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErB2 positive primary breast cancer.
  7. An open label, phase II trial of BIBW 2992(afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant treatment setting.
  8. A randomized, double-blinded, Multi-center phase 3 study of denosumab as adjuvant treatment for women with early-stage breast cancer at high risk of recurrence.
  9. A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination with Anastrozole, Compared to Anastrozole alone, in Post-menopausal Women With Hormone Receptor-positive, Endocrine Therapy-naive, Locally-advanced or Metastatic Breast Cancer
  10. A multicentre, multinational, randomized, double-blind, phase III study of IMC-1121B plus docetaxel versus placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally-recurrent or metasatic breast cancer.
  11. A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therap
  12. Phase I/II Study of Lapatinib plus oral Vinorelbine in Metastatic Breast Cancer Patients Overexpressing ErbB2
  13. A phase II study of bevacizumab and etoposide and cisplatin in breast cancer patients with brain and leptomeningeal metastasis
  14. A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation
  15. A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment
  16. A Phase 2 Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus,Dalotuzumab and Exemestane in High Proliferation,Estrogen Receptor positive Breast Cancer Patients
  17. A randomized, multicenter, open-label phase III study to evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy for patients with her2-positive primary breast cancer who have resudual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy
  18. A Phase II, multi-center, open-label, neoadjuvant,randomized study of weekly paclitaxel with or without LCL161 in patients with triple negative breast cancer
  19. A phase IIIb, multi-center, open-label, expanded access study of EVERolimus (RAD001) in combination with exemestane in post-menopausal women with EStrogen receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer
  20. A multi-national phase III clinical study comparing NK105 versus paclitaxel in patients with metastatic or recurrent breast cancer
  21. A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted-and self-administered subcutaneous trastuzumab as adjuvant therapy in patients with operable HER2-positive early breast cancer