跳至主要内容
临床试验/JPRN-UMIN000028476
JPRN-UMIN000028476已完成3 期

Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients - Cohort Study accompanying with N-SAS BC07/RESPECT

RESPECT executive committee0 个研究点目标入组 300 人开始时间: 2017年8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
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

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

发起方
RESPECT executive committee

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