Abstract:
:The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of zoledronic acid (ZOL) in the adjuvant therapy of women with stage II/III breast cancer. Here, we report the safety and tolerability profile of ZOL in this setting. Eligible patients received (neo)adjuvant chemotherapy and/or endocrine therapy and were randomised to receive neither additional treatment nor intravenous ZOL 4 mg. ZOL was administered after each chemotherapy cycle to exploit potential sequence-dependent synergy. ZOL was continued for 60 months post-randomisation (six doses in the first 6 months, eight doses in the following 24 months and five doses in the final 30 months). Serious (SAE) and non-serious adverse event (AE) data generated during the first 36 months on study were analysed for the safety population. 3,360 patients were recruited to the AZURE trial. The safety population comprised 3,340 patients (ZOL 1,665; control 1,675). The addition of ZOL to standard treatment did not significantly impact on chemotherapy delivery. SAE were similar in both treatment arms. No significant safety differences were seen apart from the occurrence of osteonecrosis of the jaw (ONJ) in the ZOL group (11 confirmed cases; 0.7%; 95% confidence interval 0.3-1.1%). ZOL in the adjuvant setting is well tolerated, and can be safely administered in addition to adjuvant therapy including chemotherapy. The adverse events were consistent with the known safety profile of ZOL, with a low incidence of ONJ.
journal_name
Breast Cancer Res Treatjournal_title
Breast cancer research and treatmentauthors
Coleman R,Woodward E,Brown J,Cameron D,Bell R,Dodwell D,Keane M,Gil M,Davies C,Burkinshaw R,Houston SJ,Grieve RJ,Barrett-Lee PJ,Thorpe Hdoi
10.1007/s10549-011-1429-ysubject
Has Abstractpub_date
2011-06-01 00:00:00pages
429-38issue
2eissn
0167-6806issn
1573-7217journal_volume
127pub_type
杂志文章,随机对照试验abstract::This study clarified the difference in the effects on serum lipids between toremifene (TOR) and tamoxifen (TAM). To remove influencing factors, we investigated adjuvant therapy for hormone receptor-positive patients with breast cancer without lymph node metastasis. The subjects were 65 patients who were enrolled in a ...
journal_title:Breast cancer research and treatment
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 杂志文章,评审
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 临床试验,杂志文章
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 杂志文章
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更新日期:1996-01-01 00:00:00
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journal_title:Breast cancer research and treatment
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doi:10.1007/s10549-004-6456-5
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journal_title:Breast cancer research and treatment
pub_type: 杂志文章
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 杂志文章,meta分析
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Breast cancer research and treatment
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journal_title:Breast cancer research and treatment
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Breast cancer research and treatment
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