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臨床試驗

目前進行中之臨床試驗:

  1. GLORIA試驗:一項以抗 Globo H 疫苗 adagloxad simolenin(OBI-822)/OBI-821作為輔助性療法治療高風險早期 Globo H 陽性 三陰性乳癌患者的第三期、隨機分配開放性試驗
  1. 一項在 HER2 低表現型乳癌患者中評估輔助治療性癌症疫苗 (AST-301、pNGVL3-hICD) 之療效和安全性的第 2 期試驗 (Cornerstone-001)
  1. 一項第III期、隨機分配、雙盲、安慰劑對照臨床試驗,評估輔助性ATEZOLIZUMAB或安慰劑加上TRASTUZUMAB EMTANSINE用於術前療法後有高風險復發的HER2陽性乳癌中的療效與安全性
  1. 一項第三期、多中心、隨機、開放性、活性對照,在接受前導性治療後有乳房或腋下淋巴結殘餘侵襲性疾病的高風險人類表皮生長因子受體 2 (HER2) 陽性原發性乳癌受試者中,比較 TRASTUZUMAB DERUXTECAN (T-DXd) 與 TRASTUZUMAB EMTANSINE (T-DM1) 之試驗
  1. 一項第III期、隨機分配、開放性、多中心試驗,針對雌激素受體陽性、第2型人類表皮生長因子受體(HER2)陰性的早期乳癌病患,評估輔助性Giredestrant相對於醫師選擇的輔助性內分泌單一療法之療效與安全性
  1. 使用Trastuzumab Deruxtecan (T-DXd)併用或不併用Pertuzumab相較於Taxane、Trastuzumab和Pertuzumab合併治療作為HER2陽性、轉移性乳癌第一線治療的第三期試驗(DESTINY-Breast09)
  1. 一項第三期、隨機分配、開放性試驗,評估在接受PHESGO+TAXANE類藥物誘導治療後,GIREDESTRANT併用PHESGO相較於PHESGO,用於先前未經治療的HER2陽性、雌激素受體陽性局部晚期或轉移性乳癌病患的療效及安全性
  1. 一項隨機分配、雙盲、第三期以 tucatinib 或安慰劑併用 trastuzumab 和 pertuzumab 作為轉移性 HER2 陽性乳癌維持療法的試驗 (HER2CLIMB-05)
  1. 一項第三期、隨機分配、雙盲、安慰劑對照試驗,針對罹患PIK3CA-突變、荷爾蒙受體-陽性 、HER2-陰性之局部晚期或轉移性乳癌病患評估INAVOLISIB併用PALBOCICLIB和 FULVESTRANT相較於安慰劑併用PALBOCICLIB和FULVESTRANT的療效與安全性
  1. 一項第三期、隨機分配、雙盲、安慰劑對照、多中心試驗,評估GDC-9545併用palbociclib相較於letrozole併用palbociclib用於雌激素受體陽性、HER2陰性、局部晚期或轉移性乳癌病患的療效與安全性
  1. SERENA-6:一項第 III 期、雙盲、隨機分配試驗,評估轉換至 AZD9833(新一代口服選擇性雌激素受體降解劑 [SERD])+ CDK4/6 抑制劑(Palbociclib 或 Abemaciclib),相較於持續接受芳香環酶抑制劑(Letrozole 或 Anastrozole)+ CDK4/6 抑制劑,於接受芳香環酶抑制劑 + CDK4/6 抑制劑的一線治療期間、可測得 ESR1 突變且無疾病惡化之賀爾蒙受體陽性 (HR+)/人類表皮生長因子受體 2 陰性 (HER2-) 轉移性乳癌
  1. 一項對於高風險、雌激素受體陽性 (ER+)、第二型人類表皮生長因子受體陰性 (HER2-) 原發性乳癌患者,評估 Nivolumab 相較於安慰劑加上前導輔助性化療與輔助性內分泌療法的隨機、多中心、雙盲、安慰劑對照第 3 期試驗
  1. 一項第三期、開放性、隨機分配,針對第一線局部復發無法手術切除或轉移性三陰性乳癌且不適合接受 PD-1/PD-L1 抑制劑療法的患者,使用 Datopotamab Deruxtecan (Dato-DXd) 相較於試驗主持人選用之化療的試驗 (TROPION-Breast02)
  1. 一項第3期、開放性、隨機分配試驗,對於在前導性全身性療法後手術切除時乳房和/或腋下淋巴結有殘餘侵襲性疾病的第I-III期三陰性乳癌患者,評估Datopotamab Deruxtecan (Dato-DXd)併用或不併用Durvalumab相較於試驗主持人選定之療法(TROPION-Breast03)
  1. 一項隨機分配、開放標記、第 3 期試驗,針對罹患先前未治療、局部晚期、無法手術或轉移性三陰性乳癌,腫瘤表現 PD-L1 的病患,比較 Sacituzumab Govitecan 和 Pembrolizumab,相較於醫師選擇的治療和 Pembrolizumab

 

臨床試驗已發表之文獻 :

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)

 

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