Some images has been designed using resources from Unsplash & Pixabay & Pexels & Freepik and some icons from Flaticon
跳到主要內容
:::
:::

臨床試驗

 

目前收案中(~2019.09):

  Title Name (Chinese) 階段
1 一項第三期、雙盲、隨機分配試驗,針對經組織學確認、局部晚期 (無法手術) 或轉移性三陰性乳癌患者,評估 capivasertib + paclitaxel 相較於安慰劑 + paclitaxel做為第一線治療的療效及安全性(TNBC) D3614C00001 Phase III
2
一項第三期、雙盲、隨機分配試驗,針對經組織學確認、局部晚期 (無法手術) 或轉移性三陰性乳癌患者,評估 capivasertib + paclitaxel 相較於安慰劑 + paclitaxel做為第一線治療的療效及安全性(TNBC) (D3614C00001)
Phase III
3 比較 Balixafortide 合併 Eribulin 相較於單獨給予 Eribulin 使用於 HER2 陰性、局部復發或轉移性乳癌病患的一項跨國、第 3 期、多中心、隨機分配、開放性試驗 (POL6326-009) Phase III
4 一項以adagloxad simolenin(OBI 822)/OBI 821治療高風險早期三陰性乳癌患者(定義為接受前導性化療後有殘餘侵襲性疾病,或有 ≥ 4處腋下淋巴結呈陽性)的第三期、隨機分配、雙盲、安慰劑對照試驗 (OBI-822-011) Phase III
5 一項第三期、多中心、隨機分配、開放標示試驗,在可手術之三陰性乳癌患者中, 比較 ATEZOLIZUMAB ( 抗 PD-L1 抗體) 併用以ANTHRACYCLINE/TAXANE 類為主的輔助性化療與單獨的化學治療  (WO39391) Phase III
6 一項第三期、多中心、隨機、開放標示、活性藥物對照在曾接受trastuzumab和taxane治療的HER2陽性、無法切除和/或轉移性乳癌受試 者 , 比 較DS-8201a( 一 種 抗HER2抗 體 藥 物 複 合 體 ) 和ado-trastuzumab emtansine(T-DM1)的試驗  (DS8201-A-U302) Phase III
7 針對台灣女性乳癌的腫瘤特異性進行全面性精準醫學基因分析  (QCR18002) Phase II
8 一項第 II 期、開放標記、隨機分配、三治療組的多中心試驗,針對晚期三陰性乳癌患者,評估 LAG525 併用 spartalizumab (PDR001)、併用 spartalizumab 和 carboplatin、併用 carboplatin 等合併療法,做為第一線或第二線治療的療效及安全性  Phase II
9 一項隨機分配、多中心、雙盲設計的第3期試驗,評估EG12014 (EirGenix Trastuzumab)相較於Herceptin®作為HER2陽性早期乳癌病人進行含Anthracycline/Paclitaxel全身性治療時的前輔助治療的療效及安全性  (EGC002) Phase III
10 一項第III期、隨機分配、多中心、開放性、兩組試驗,在HER2陽性早期乳癌病患中,評估皮下投予PERTUZUMAB加上TRASTUZUMAB之?固定劑量複合療法併用化療的藥動學、療效與安全性  (WO40324) Phase III
11 一項第II期開放性、隨機分配、多中心試驗,評估DNA損壞修復標靶藥物併用Olaparib相較於Olaparib單一療法,用於治療以同源重組修復(HRR)相關基因(包括BRCA1/2)不同變異組別之轉移性三陰性乳癌病患的療效與安全性 (VIOLETTE) Phase II

 

 

臨床試驗已發表之文獻 (~2019):

1

Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2.  Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagie??o-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortés J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaër S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J.    Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18. (IF=7.191, 2017)  (Pubmed)

2

Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial.   Baselga J, Im SA, Iwata H, Cortés J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagie??o-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M.      Lancet Oncol. 2017 Jul;18(7):904-916. Epub 2017 May 30. (IF=36.418 3/222, ONCOLOGY, 2017 (Pubmed)

3

Biomarker analysis of the NeoSphere study: pertuzumab, trastuzumab, and docetaxel versus trastuzumab plus docetaxel, pertuzumab plus trastuzumab, or pertuzumab plus docetaxel for the neoadjuvant treatment of HER2 positive breast cancer.  Bianchini G, Kiermaier A, Bianchi GV, Im YH, Pienkowski T, Liu MC, Tseng LM, Dowsett M, Zabaglo L, Kirk S, Szado T, Eng-Wong J, Amler LC, Valagussa P, Gianni L.  Breast Cancer Res. 2017 Feb 9;19(1):16. (IF=6.142, 34/222, ONCOLOGY, 2017) (Pubmed)

4

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.  Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J.     N Engl J Med. 2016 Nov 3;375(18):1738-1748. (IF=79.258, 1/154, MEDICINE, GENERAL & INTERNAL, 2017) (Pubmed)

5

5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial.  Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, Staros?awska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi GV, Magazzù D, McNally V, Douthwaite H, Ross G, Valagussa P.     Lancet Oncol. 2016 Jun;17(6):791-800 (IF=36.418, 3/222, ONCOLOGY, 2017)   (PubMed)

6

Molecular Alterations and Everolimus Efficacy in Human Epidermal Growth Factor Receptor 2-Overexpressing Metastatic Breast Cancers: Combined Exploratory Biomarker Analysis From BOLERO-1 and BOLERO-3. André F, Hurvitz S, Fasolo A, Tseng LM, Jerusalem G, Wilks S, O'Regan R, Isaacs C, Toi M, Burris H2, He W, Robinson D, Riester M, Taran T, Chen D, Slamon D.       J Clin Oncol. 2016 Jun 20;34(18):2115-24(IF=26.303, 4/222, ONCOLOGY, 2017)   (PubMed)

7

Immune modulation of pathologic complete response after neoadjuvant HER2-directed therapies in the NeoSphere trial. Bianchini G, Pusztai L, Pienkowski T, Im YH, Bianchi GV, Tseng LM, Liu MC, Lluch A, Galeota E, Magazzù D, de la Haba-Rodríguez J, Oh DY, Poirier B, Pedrini JL, Semiglazov V, Valagussa P, Gianni L. Ann Oncol. 2015 Dec;26(12):2429-36. IF= 7.040  (PubMed)

8

Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Lancet Oncol. 2015 Jul;16(7):816-29. IF= 24.690  (PubMed)

9

Bevacizumab preconditioning followed by Etoposide and Cisplatin is highly effective in treating brain metastases of breast cancer progressing from whole-brain radiotherapy. Lu YS, Chen TW, Lin CH, Yeh DC, Tseng LM, Wu PF, Rau KM, Chen BB, Chao TC, Huang SM, Huang CS, Shih TT, Cheng AL; Taiwan Breast Cancer Consortium.  Clin Cancer Res. 2015 Apr 15;21(8):1851-8. IF=8.722  (PubMed)

10

Biomarker analysis of neoadjuvant doxorubicin/cyclophosphamide followed by ixabepilone or Paclitaxel in early-stage breast cancer. Horak CE, Pusztai L, Xing G, Trifan OC, Saura C, Tseng LM, Chan S, Welcher R, Liu D.  Clin Cancer Res. 2013 Mar 15;19(6):1587-95. IF=8.722 (PubMed)

11

Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA).   Schneeweiss A1, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortés J.  Ann Oncol 2013 Sep;24(9):2278-84 IF=6.578 (PubMed)

12

Neoadjuvant doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early stage breast cancer and evaluation of βIII-tubulin expression as a predictive marker. Saura C, Tseng LM, Chan S, Chacko RT, Campone M, Manikhas A, Nag SM, Leichman CG, Dasappa L, Fasching PA, Hurtado de Mendoza F, Symmans WF, Liu D, Mukhopadhyay P, Horak C, Xing G, Pusztai L.  Oncologist. 2013;18(7):787-94. IF=4.865  (PubMed)

13

Quality of life after palliative radiation therapy for patients with painful bone metastases: results of an international study validating the EORTC QLQ-BM22. Zeng L, Chow E, Bedard G, Zhang L, Fairchild A, Vassiliou V, Alm El-Din MA, Jesus-Garcia R, Kumar A, Forges F, Tseng LM*, Hou MF, Chie WC, Bottomley A.  Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e337-42. IF=4.258 (PubMed)

14

International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases. Chow E, Nguyen J, Zhang L, Tseng LM, Hou MF, Fairchild A, Vassiliou V, Jesus-Garcia R, Alm El-Din MA, Kumar A, Forges F, Chie WC, Bottomley A; European Organization for Research Treatment of Cancer Quality of Life Group. Cancer. 2012 Mar 1;118(5):1457-65. IF=5.201 (PubMed)

15

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team.  Lancet. 2012 Feb 18;379(9816):633-40. IF=39.06 (PubMed)

16

Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P.  Lancet Oncol. 2012 Jan;13(1):25-32. IF=25.117 (PubMed)

乳醫中心臨床試驗截至2019.09共執行國際(內)多中心達70件以上, 已有23篇SCI paper發表 (ex:HERA, 、BETH, Beatrice, Neosphere、NeoAllto、Allto, Tryphnea, BOLERO-1、BELLE-2, Aphinity,Kristine, Katherine, Kailitin, BIBW2992, OBI821/822……etc)

 

最後更新:

回到最上