Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial

Gnant Michael; Pfeiler Georg; Dubsky Peter C.; Hubalek Michael; Greil Richard; Jakesz Raimund; Wette Viktor; Balic Marija; Haslbauer Ferdinand; Melbinger Elisabeth; Bjelic-Radisic Vesna; Artner-Matuschek Silvia; Fitzal Florian; Marth Christian; Sevelda Paul; Mlineritsch Brigitte; Steger Guenther G.; Manfreda Diether; Exner Ruth; Egle Daniel; Bergh Jonas; Kainberger Franz; Talbot Susan; Warner Douglas; Fesl Christian; Singer Christian F.

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Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial

机译：乳腺癌（ABCSG-18）中的佐剂Denosumab：多期，随机，双盲，安慰剂对照试验

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Background Adjuvant endocrine therapy compromises bone health in patients with breast cancer, causing osteopenia, osteoporosis, and fractures. Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects. In this trial, we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal, aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer.

机译：背景技术佐剂内分泌治疗会损害乳腺癌患者的骨骼健康，导致骨质增长，骨质疏松症和骨折。诸如双膦酸盐的反射处理防止并抵消这些副作用。在该试验中，我们旨在探讨抗级配体抗体Denosumab在绝经后芳香酶抑制剂治疗患者的早期激素受体阳性乳腺癌患者的影响。

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来源
《The Lancet》 |2015年第9992期|共11页
作者
Gnant Michael; Pfeiler Georg; Dubsky Peter C.; Hubalek Michael; Greil Richard; Jakesz Raimund; Wette Viktor; Balic Marija; Haslbauer Ferdinand; Melbinger Elisabeth; Bjelic-Radisic Vesna; Artner-Matuschek Silvia; Fitzal Florian; Marth Christian; Sevelda Paul; Mlineritsch Brigitte; Steger Guenther G.; Manfreda Diether; Exner Ruth; Egle Daniel; Bergh Jonas; Kainberger Franz; Talbot Susan; Warner Douglas; Fesl Christian; Singer Christian F.;
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作者单位

Med Univ Vienna Dept Surg A-1090 Vienna Austria;

Med Univ Vienna Ctr Comprehens Canc A-1090 Vienna Austria;

Med Univ Vienna Dept Surg A-1090 Vienna Austria;

Med Univ Innsbruck Dept Gynecol A-6020 Innsbruck Austria;

Paracelsus Med Univ Salzburg Dept Internal Med 3 Salzburg Austria;

Med Univ Vienna Dept Surg A-1090 Vienna Austria;

Breast Ctr Doctors Off Wette St Veit An Der Glan Austria;

Med Univ Graz Dept Oncol Graz Austria;

Hosp Vocklabruck Dept Internal Med Vocklabruck Austria;

Hosp Wolfsberg Dept Surg Wolfsberg Austria;

Med Univ Graz Dept Gynecol Graz Austria;

Breast Ctr Hosp Hanusch Vienna Dept Surg Vienna Austria;

Med Univ Vienna Dept Surg A-1090 Vienna Austria;

Med Univ Innsbruck Dept Gynecol A-6020 Innsbruck Austria;

Hosp Hietzing Dept Gynecol Vienna Austria;

Paracelsus Med Univ Salzburg Dept Internal Med 3 Salzburg Austria;

Med Univ Vienna Dept Internal Med 1 A-1090 Vienna Austria;

Doctors Off Manfreda Klagenfurt Austria;

Med Univ Vienna Dept Surg A-1090 Vienna Austria;

Med Univ Innsbruck Dept Gynecol A-6020 Innsbruck Austria;

Karolinska Inst Karolinska Oncol Dept Oncol Radiumhemmet Stockholm Sweden;

Med Univ Vienna Dept Biomed Imaging &

Image Guided Therapy A-1090 Vienna Austria;

Amgen Ltd Uxbridge Middx England;

Amgen Inc Thousand Oaks CA 91320 USA;

Austrian Breast &

Colorectal Canc Study Grp Dept Stat Vienna Austria;

Med Univ Vienna Ctr Comprehens Canc A-1090 Vienna Austria;

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正文语种 eng
中图分类医药、卫生;
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1. Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial [J] . Gnant Michael, Pfeiler Georg, Dubsky Peter C., The Lancet . 2015,第9992期

机译：乳腺癌（ABCSG-18）中的佐剂Denosumab：多期，随机，双盲，安慰剂对照试验
2. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial [J] . Chan Arlene, Delaloge Suzette, Holmes Frankie A., The lancet oncology . 2016,第3期

机译：曲妥珠单抗辅助治疗后HER-2阳性的HER2阳性乳腺癌患者（ExteNET）：一项多中心，随机，双盲，安慰剂对照的3期试验
3. The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial. [J] . Semiglasov VF, Stepula VV, Dudov A, Anticancer Research: International Journal of Cancer Research and Treatment . 2004,第2C期

机译：标准化的槲寄生提取物PS76A2可改善接受辅助CMF化疗的乳腺癌患者的QoL：一项随机，安慰剂对照，双盲，多中心的临床试验。
4. EFFECT OF TARGETED PULSED ELECTROMAGNETIC FIELD THERAPY ON CANINE POST-OPERATIVE HEMILAMINECTOMY: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL [C] . ACVS Veterinary Symposium . 2018

机译：靶向脉冲电磁场治疗对犬术后血栓切除术的影响：双盲，随机，安慰剂对照临床试验
5. A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Effect of Infliximab on General Cognition in a Population of Depressed Individuals with Bipolar Disorder Type I/II [D] . Pan, Zihang. 2018

机译：一项随机，双盲，安慰剂对照的临床试验，评估英夫利昔单抗对I / II型双相情感障碍抑郁症患者总体认知的影响
6. Extended report: Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose–response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)—a 12-month multicentre randomised double-blind placebo-controlled phase II clinical trial [O] . Tsutomu Takeuchi, Yoshiya Tanaka, Naoki Ishiguro, -1

机译：扩展报告：地诺单抗对日本类风湿关节炎患者的影响：风湿性关节炎甲氨蝶呤患者中AMG 162（Denosumab）的剂量反应研究以验证其对骨侵蚀（DRIVE）的抑制作用-一项为期12个月的多中心随机研究双盲安慰剂对照的II期临床试验
7. Faculty Opinions recommendation of Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose-response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)-a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial. [O] . Sakae Tanaka 2019

机译：教师意见Denosumab对日本类风湿性关节炎患者的建议：AMG 162（Denosumab）对类风湿性关节炎患者对甲氨蝶呤抑制骨侵蚀（驱动）-A的抑制作用（驱动）-A 12个月，Multicentre的抑制作用的剂量 - 反应研究。随机，双盲，安慰剂控制，II期临床试验。

Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebo-controlled trial

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