Phase III Randomized Trial of Droloxifene and Tamoxifen As First-Line Endocrine Treatment of ER/PgR-Positive Advanced Breast Cancer

作者: A. Buzdar , D. Hayes , A. El-Khoudary , S. Yan , P. Lønning

DOI: 10.1023/A:1015229630260

关键词:

摘要: Purpose:This trial was designed to demonstrate equivalence between droloxifene 40 mg/d and tamoxifen 20 as first-line treatment in pre- post-menopausal women with ER+ and/or PgR+ advanced breast cancer based on time disease progression tumor response.

参考文章(23)
Christopher Jennison, Bruce W. Turnbull, Interim analyses: the repeated confidence interval approach Journal of the royal statistical society series b-methodological. ,vol. 51, pp. 305- 334 ,(1989) , 10.1111/J.2517-6161.1989.TB01433.X
H Yamauchi, A O'Neill, R Gelman, W Carney, D Y Tenney, S Hösch, D F Hayes, Prediction of response to antiestrogen therapy in advanced breast cancer patients by pretreatment circulating levels of extracellular domain of the HER-2/c-neu protein. Journal of Clinical Oncology. ,vol. 15, pp. 2518- 2525 ,(1997) , 10.1200/JCO.1997.15.7.2518
Per M. Ueland, Einar Solheim, Ernst A. Lien, Distribution of tamoxifen and its metabolites in rat and human tissues during steady-state treatment. Cancer Research. ,vol. 51, pp. 4837- 4844 ,(1991)
K Leitzel, Y Teramoto, K Konrad, V M Chinchilli, G Volas, H Grossberg, H Harvey, L Demers, A Lipton, Elevated serum c-erbB-2 antigen levels and decreased response to hormone therapy of breast cancer. Journal of Clinical Oncology. ,vol. 13, pp. 1129- 1135 ,(1995) , 10.1200/JCO.1995.13.5.1129
Svein I. Helle, Gun B. Anker, Michael Tally, Kerstin Hall, Per E. Lønning, Influence of droloxifene on plasma levels of insulin-like growth factor (IGF)-I, pro-IGF-IIE, insulin-like growth factor binding protein (IGFBP)-1 and IGFBP-3 in breast cancer patients The Journal of Steroid Biochemistry and Molecular Biology. ,vol. 57, pp. 167- 171 ,(1996) , 10.1016/0960-0760(95)00257-X
J. Bellmunt, L. Solé, European early phase II dose-finding study of droloxifene in advanced breast cancer. American Journal of Clinical Oncology. ,vol. 14, pp. 36- 39 ,(1991) , 10.1097/00000421-199112002-00008
J Geisler, H Haarstad, S Gundersen, N Raabe, S Kvinnsland, P E Lønning, Influence of treatment with the anti-oestrogen 3-hydroxytamoxifen (droloxifene) on plasma sex hormone levels in postmenopausal patients with breast cancer. Journal of Endocrinology. ,vol. 146, pp. 359- 363 ,(1995) , 10.1677/JOE.0.1460359
Max Hasmann, Benno Rattel, Roland Löser, Preclinical data for Droloxifene Cancer Letters. ,vol. 84, pp. 101- 116 ,(1994) , 10.1016/0304-3835(94)90364-6
Helce Haarstad, Stein Gundersen, Erik Wist, Nils Raabe, Olav Mella, Stener Kvinnsland, Droloxifene--a new anti-estrogen. A phase II study in advanced breast cancer. Acta Oncologica. ,vol. 31, pp. 425- 428 ,(1992) , 10.3109/02841869209088284