TRIAL COMPARING ADJUVANT CLODRONATE THERAPY VERSUS PLACEBO IN BREAST CANCER

比较氯膦酸盐辅助治疗与安慰剂治疗乳腺癌的试验

• 批准号: 7376349
• 负责人: WILLIAM MCKINNON
• 金额: $ 0.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376349
• 关键词: TRIAL; COMPARING; ADJUVANT; CLODRONATE; THERAPY

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 will evaluate the worth of clodronate, a second-generation biphosphonate, in women with early-stage breast cancer. 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. For patients undergoing sentinel node biopsy, only those participating in NSABP B-32 will be eligible. If sentinel node biopsy is performed outside the B-32 protocol, completion of axillary dissection is required. 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 and will be documented in the study record. The exact regimen, dose and duration wil be at the discretion of the investigator. Patients will be followed every six months for the first five years and every 12 months thereafter. In order to fully determine treatment effects on both bone and all other potential sites of recurrence, each patient will be followed for sites of recurrence until the development of both bone and non-bone metastasis (this includes visceral sites, soft tissue sites and/or local/regional recurrence sites) have occurred. Patients will continue their assigned therapy for three years or until first definite bone metastasis, even if the patient has had a prior non-skeletal recurrence or second primary cancer. The primary aims of this trial are: 1) to determine whether 1,600 mg/day of clodronate, given for three years, either alone or in addition to adjuvant chemotherapy and/or hormonal therapy will improve disease-free survival; 2) to evaluate whether adjuvant clodronate results in a reduction in skeletal metastases, skeletal-related morbidity, non-skeletal metastases, and an improvement in relapse-free survival and overall survival; and 3) to investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastases.

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、安慰剂对照试验将评估氯膦酸盐（一种第二代双膦酸盐）在早期乳腺癌妇女中的价值。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。对于接受前哨淋巴结活检的患者，只有参加NSABP B-32的患者才有资格。如果前哨淋巴结活检在B-32方案之外进行，则需要完成腋窝淋巴结清扫。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酌情决定，并记录在研究记录中。确切的方案、剂量和持续时间将由研究者决定。患者将在前五年每六个月随访一次，此后每12个月随访一次。为了充分确定治疗对骨和所有其他潜在复发部位的影响，将对每例患者的复发部位进行随访，直至发生骨和非骨转移（包括内脏部位、软组织部位和/或局部/区域复发部位）。患者将继续接受指定的治疗3年或直至首次明确的骨转移，即使患者既往有非骨骼复发或第二原发性癌症。 本试验的主要目的是：1）确定单独或与辅助化疗和/或激素治疗一起给予1,600 mg/天氯膦酸盐三年是否会改善无病生存率; 2）评估辅助氯膦酸盐是否导致骨转移、与肿瘤相关的发病率、非骨转移的减少，以及无复发生存期和总生存期的改善;和3）研究骨转换血清标志物作为骨转移发展预后因素的相关性。