NSABP-B34

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。该III期前瞻性、随机、双盲、安慰剂对照试验在早期乳腺癌女性中进行，旨在评估氯膦酸盐（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，在一项小型的公开标签研究中，对乳腺癌患者的骨转移有有益的影响。本研究的主要目的是确定连续3年每天服用1600mg氯膦酸钠，无论是单独服用还是与辅助化疗和/或激素治疗联合使用，是否会提高无病生存期。本研究还将评估氯膦酸钠佐剂是否能降低骨骼转移、骨骼相关发病率、非骨骼转移的发生率，并改善无复发生存期和总生存期。为了有资格参加这项试验，妇女必须接受全乳房切除术或乳房肿瘤切除术，同时进行腋窝清扫或前哨淋巴结活检。患者将根据年龄、淋巴结状态、ER和/或PgR受体状态进行分层。患者必须没有转移性疾病的证据。辅助化疗和/或他莫昔芬的管理将由研究者自行决定。确切的治疗方案、剂量和持续时间将由研究者自行决定，而不是研究的一部分。加入氯膦酸盐或安慰剂是本研究的主题。

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.