Excessive false-positive errors in single-arm phase II trials: A simulation-based analysis

被引:0
|
作者
Tang, H. [1 ]
Foster, N. R. [1 ]
Grothey, A. [1 ]
Ansell, S. M. [1 ]
Sargent, D. J. [1 ]
机构
[1] Mayo Clin, Rochester, MN USA
关键词
D O I
暂无
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
6512
引用
收藏
页数:2
相关论文
共 50 条
  • [41] Bayesian enhancement two-stage design for single-arm phase II clinical trials with binary and time-to-event endpoints
    Shi, Haolun
    Yin, Guosheng
    BIOMETRICS, 2018, 74 (03) : 1055 - 1064
  • [42] Trastuzumab combined with irinotecan in patients with HER2-positive metastatic colorectal cancer: A phase II multicenter single-arm study and exploratory biomarker analysis
    Xu, Ting
    Wang, Xicheng
    Xin, Ying
    Wang, Zhenghang
    Wang, Yakun
    Qi, Changsong
    Liu, Dan
    Li, Yanyan
    Gong, Jifang
    Li, Jian
    Huang, Depei
    Shen, Lin
    JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (04)
  • [43] Combined pyrotinib and fulvestrant for hormone receptor-positive and HER2-positive metastatic breast cancer: A multicenter, single-arm, phase II trial
    Zhao, Jianli
    Yu, Yunfang
    Ren, Wei
    Ding, Linxiaoxiao
    Chen, Yongjian
    Yuan, Peng
    Yue, Jian
    Yang, Yaping
    Zou, Guorong
    Chen, Tao
    Chai, Jie
    Zhang, Li
    Wu, Wenjing
    Zeng, Yinduo
    Gui, Xiujuan
    Cai, Yangyang
    Luo, Simin
    Yuan, Zhongyu
    Zhang, Kang
    Yao, Herui
    Wang, Ying
    MEDCOMM, 2025, 6 (01):
  • [44] A Phase II Single-arm Study of Palbociclib in Patients With HER2-positive Breast Cancer With Brain Metastases and Analysis of ctDNA in Patients With Active Brain Metastases
    Shah, Ami N.
    Santa-Maria, Cesar A.
    Mukhija, Dhruvika
    Shah, Nikita
    Kang, Anthony K.
    Kumthekar, Priya
    Burdett, Kirsten
    Chandra, Shruti
    Chang, Jenny
    Tsarwhas, Dean
    Woodman, Jill
    Jovanovic, Borko
    Gerratana, Lorenzo
    Gradishar, William
    Cristofanilli, Massimo
    CLINICAL BREAST CANCER, 2023, 23 (03) : 324 - 329
  • [45] Pyrotinib combined with metronomic etoposide in heavily pretreated HER2-positive metastatic breast cancer: a single-arm, phase II study
    Liu, Jiaxuan
    He, Maiyue
    Jiang, Mingxia
    Zhou, Shihan
    Zhang, Mengqi
    Li, Yiqun
    Chen, Shanshan
    Cai, Ruigang
    Mo, Hongnan
    Lan, Bo
    Ma, Fei
    Xu, Binghe
    Li, Qiao
    BMC CANCER, 2024, 24 (01)
  • [46] Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance)
    Hwang, E. Shelley
    Hyslop, Terry
    Hendrix, Laura H.
    Duong, Stephanie
    Bedrosian, Isabelle
    Price, Elissa
    Caudle, Abigail
    Hieken, Tina
    Guenther, Joseph
    Hudis, Clifford A.
    Winer, Eric
    Lyss, Alan P.
    Dickson-Witmer, Diana
    Hoefer, Richard
    Ollila, David W.
    Hardman, Timothy
    Marks, Jeffrey
    Chen, Yunn-Yi
    Krings, Gregor
    Esserman, Laura
    Hylton, Nola
    JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (12) : 1284 - +
  • [47] Bayesian Predictive Probability Based on a Bivariate Index Vector for Single-Arm Phase II Study With Binary Efficacy and Safety Endpoints
    Yoshimoto, Takuya
    Shinoda, Satoru
    Yamamoto, Kouji
    Tahata, Kouji
    PHARMACEUTICAL STATISTICS, 2025, 24 (01)
  • [48] A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC).
    Choueiri, Toni K.
    Plimack, Elizabeth R.
    Arkenau, Hendrik-Tobias
    Jonasch, Eric
    Heng, Daniel Yick Chin
    Powles, Thomas
    JOURNAL OF CLINICAL ONCOLOGY, 2017, 35 (06)
  • [49] Clinician-trialist rounds: 18. Should young (and old!) clinician-trialists perform single-arm Phase II futility trials?
    Sackett, David L.
    CLINICAL TRIALS, 2013, 10 (06) : 987 - 989
  • [50] Neoadjuvant niraparib monotherapy in homologous recombination deficiency-positive advanced ovarian cancer: a prospective, multicenter, single-arm, phase II study (NANT)
    Li, Huayi
    Liu, Dan
    Zhang, Wei
    Wang, Ping
    Li, Jundong
    Shan, Wanying
    Liu, Ronghua
    Chen, Gang
    Wu, Mingfu
    Li, Xiao
    Liu, Cheng
    Yin, Rutie
    Zhou, Shengtao
    Li, Maomao
    He, Shanyang
    Zhao, Guangnian
    Song, Kun
    Hong, Li
    Ma, Ding
    Gao, Qinglei
    INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2024, 34 (SUPPL_3) : A8 - A9