AZURE BR 2-03 - Does Adjuvant Zoledronic acid reduce recurrence in patients with high risk localised breast cancer?

Prof Robert Coleman, The University of Sheffield, United Kingdom0 个研究点目标入组 3,300 人开始时间: 2006年7月11日最近更新: 2020年1月13日

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•Patients with Stage II/III primary breast cancer - Receiving or scheduled to receive neoadjuvant or adjuvant chemotherapy and/or endocrine therapy- Performance status Eastern Cooperative Oncology Group 0 or 1- Reliable and appropriate contraception. Patient must have given written informed consent prior to study specific procedures.

•Metastatic or recurrent breast cancer or a history of breast cancer (excluding ductal carcinoma in situ or lobular carcinoma in situ)- History of prior cancers within the preceding five years (including previous contralateral breast cancer)- History of diseases with influence on bone metabolism such as Paget's disease of the bone, primary hypothyroidism or osteoporosis requiring treatment at the time of study entry or within 6 months- Prior treatment with bisphosphonates within the past year- Serum creatinine > 1.5 x upper limit of normal- Known hypersensitivity to bisphosphonates- Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw- Recent (within 4 weeks of study entry) or planned dental or jaw surgery (eg extractions, implants)- Pregnancy or breast feeding.

发起方

Prof Robert Coleman, The University of Sheffield, United Kingdom