NSABP-B34

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项III期前瞻性随机、双盲、安慰剂对照试验在早期乳腺癌妇女中进行，将评估氯膦酸盐（第二代双膦酸盐）的价值。双膦酸盐已被证明可以阻止骨骼的分解，在一项小型开放标签研究中，对乳腺癌患者的骨转移有有益的影响。这项研究的主要目的是确定1600毫克/天的氯膦酸盐给药3年，无论是单独或辅助化疗和/或激素治疗将提高无病生存。这项研究还将评估辅助氯膦酸盐是否会导致骨转移发生率、骨相关发病率、非骨转移发生率的降低，以及无复发生存率和总生存率的改善。要符合这项试验的条件，女性必须接受全乳房切除术或乳房肿瘤切除术，并进行腋窝淋巴结清扫或前哨淋巴结活检。将根据年龄、淋巴结状态和ER和/或PgR受体状态对患者进行分层。患者必须没有转移性疾病的证据。辅助化疗和/或他莫昔芬的给药将由研究者决定。确切的方案、剂量和持续时间将由研究者决定，不属于研究的一部分。本研究的主题是添加氯膦酸盐或安慰剂。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase III prospective randomized, double-blind, placebo-controlled trial in women with early-stage breast cancer that will evaluate the worth of clodronate, a second-generation bisphosphonate. Bisphosphonates have been shown to block the breakdown of bones, and in one small open label study, had a beneficial effect on bone metastases in patients with breast cancer. This study's primary aim is to determine whether 1600 mg/day of clodronate administered for 3 years, whether alone or in addition to adjuvant chemotherapy and/or hormonal therapy will improve disease-free survival. This study will also evaluate whether adjuvant clodronate results in a reduction in the incidence of skeletal metastasis, skeletal-related morbidity, non-skeletal metastases, and an improvement in relapse-free survival and overall survival. To qualify for this trial, women must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. Patients will be stratified according to age, nodal status and ER and or PgR receptor status. Patients must have no evidence of metastatic disease. The administration of adjuvant chemotherapy and/or tamoxifen will be at the discretion of the investigator. The exact regimen, dose and duration will be at the discretion of the investigator and is not part of the study. It is the addition of either clodronate or placebo that is the subject of this study.