JPRN-UMIN000002349已完成3 期
Evaluation of Trastuzumab without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial - N-SAS BC07/RESPECT
RESPECT executive committee0 个研究点目标入组 275 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
研究概览
简要总结
Three-year DFS was 89.5% with trastuzumab monotherapy vs. 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 years, restricted mean survival time differed by -0.39 months. The primary objective of noninferiority was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. In light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 70years-old 至 81years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) 2. Postoperative histological axillary lymph node metastasis >=4 3. Axillary lymph node is not histologically evaluated 4. Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site) 5. History of drug-related allergy which could hinder planned treatment 6. Any history or complication of following cardiac disorders - History of congestive heart failure, cardiac infarction - Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease 7. Poorly controlled hypertension (ex. Systolic arterial pressure >=180 mmHg or diastolic blood pressure >=100 mmHg) 8. Poorly controlled diabetes 9. Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL) 10. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms 11. Ineligible to the trial based on decision of an investigator
研究者
相似试验
尚未招募
3 期
Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial.CTRI/2023/07/055523Tata Memorial Hospital
已完成
3 期
National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]Breast CancerNCT01104935Comprehensive Support Project for Oncology Research275
已完成
3 期
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric CancerHER2-positive metastatic gastroesophageal junction or gastric cancerJPRN-jRCT2080222112Chugai Pharmaceutical Co., Ltd.780
已完成
3 期
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast CancerStage IV Breast CancerBreast CancerNCT00146549Dana-Farber Cancer Institute250
进行中（未招募）
1 期
Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)EUCTR2014-004432-18-NLErasmus MC Cancer Institute37