PDF(Pubmed)
Abstract：
UNASSIGNED: Despite neoadjuvant hormone therapy (NHT) is being underused, it is an effective treatment for luminal tumors at a lower cost and with fewer side effects compared to those associated with neoadjuvant chemotherapy (NCT). The lack of robust comparative data between NHT and NCT is a factor that limits its use in clinical practice.
UNASSIGNED: This study will be a randomized, open-label, non-inferiority clinical trial. Patients diagnosed with HER2-negative luminal-subtype breast cancer will be identified at the time of diagnosis. Menopausal patients randomized for NHT should receive anastrozole for at least six months. Premenopausal women should receive anastrozole associated with subcutaneous goserelin acetate every 12 weeks for at least six months. Patients randomized for NCT will receive a standard institutional regimen based on anthracyclines and taxanes. Sample size was calculated considering the CPS + EG as a method for evaluating response and prognosis, where a score <3 was defined as good. The non-inferiority margin for NHT was set at 15%. The study considered a power of 80%, a significance level of 5%, and an outcome proportion in each group of 69%, resulting in 118 patients in each group. We estimated at 10% of losses, resulting in a sample of 130 patients in each group.
UNASSIGNED: The non-inferiority of NHT in relation to NCT will provide further evidence that replacing NCT with NHT is safe and effective in eligible patients, which is particularly relevant for populations with limited access to health services and for institutions with few available resources.
UNASSIGNED: This study will be a randomized, open-label, non-inferiority clinical trial. Patients diagnosed with HER2-negative luminal-subtype breast cancer will be identified at the time of diagnosis. Menopausal patients randomized for NHT should receive anastrozole for at least six months. Premenopausal women should receive anastrozole associated with subcutaneous goserelin acetate every 12 weeks for at least six months. Patients randomized for NCT will receive a standard institutional regimen based on anthracyclines and taxanes. Sample size was calculated considering the CPS + EG as a method for evaluating response and prognosis, where a score <3 was defined as good. The non-inferiority margin for NHT was set at 15%. The study considered a power of 80%, a significance level of 5%, and an outcome proportion in each group of 69%, resulting in 118 patients in each group. We estimated at 10% of losses, resulting in a sample of 130 patients in each group.
UNASSIGNED: The non-inferiority of NHT in relation to NCT will provide further evidence that replacing NCT with NHT is safe and effective in eligible patients, which is particularly relevant for populations with limited access to health services and for institutions with few available resources.
摘要：
未经批准：尽管新辅助激素治疗（NHT）未得到充分利用，与新辅助化疗(NCT)相关的治疗方法相比,它是一种治疗管腔肿瘤的有效方法,成本较低,副作用较少.NHT和NCT之间缺乏可靠的比较数据是限制其在临床实践中使用的因素。
未经评估：这项研究将是一项随机研究，开放标签，非劣效性临床试验。诊断为HER2阴性管腔亚型乳腺癌的患者将在诊断时进行鉴定。随机接受NHT的绝经期患者应接受阿那曲唑治疗至少6个月。绝经前妇女应每12周接受一次与醋酸戈舍瑞林皮下相关的阿那曲唑，持续至少6个月。随机接受NCT的患者将接受基于蒽环类和紫杉烷类的标准机构治疗方案。考虑到CPS+EG作为评估反应和预后的方法，计算样本量。其中得分<3被定义为良好。NHT的非劣效性幅度设定为15%。该研究认为功率为80％，5%的显著性水平，每组的结果比例为69%，每组118名患者。我们估计损失的10%，导致每组130名患者的样本。
UNASSIGNED：NHT与NCT的非劣效性将提供进一步的证据，证明在符合条件的患者中，用NHT代替NCT是安全有效的，这对于获得卫生服务有限的人群和可用资源很少的机构尤其重要。
未经评估：这项研究将是一项随机研究，开放标签，非劣效性临床试验。诊断为HER2阴性管腔亚型乳腺癌的患者将在诊断时进行鉴定。随机接受NHT的绝经期患者应接受阿那曲唑治疗至少6个月。绝经前妇女应每12周接受一次与醋酸戈舍瑞林皮下相关的阿那曲唑，持续至少6个月。随机接受NCT的患者将接受基于蒽环类和紫杉烷类的标准机构治疗方案。考虑到CPS+EG作为评估反应和预后的方法，计算样本量。其中得分<3被定义为良好。NHT的非劣效性幅度设定为15%。该研究认为功率为80％，5%的显著性水平，每组的结果比例为69%，每组118名患者。我们估计损失的10%，导致每组130名患者的样本。
UNASSIGNED：NHT与NCT的非劣效性将提供进一步的证据，证明在符合条件的患者中，用NHT代替NCT是安全有效的，这对于获得卫生服务有限的人群和可用资源很少的机构尤其重要。
