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临床试验/NCT05474391
NCT05474391进行中(未招募)不适用

The Value of MammaPrint in Adjuvant Therapy Decision Among Pre-menopausal Breast Cancer Patients: a Survey Based on Clinical Staff

Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Treatment decision survey

研究概览

简要总结

Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • pre-menopausal breast cancer patients aged less than 50 years old.
  • Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
  • receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
  • TNM staging: T1b-T2N0-1M
  • molecular subtype: ER positive/HER2 negative.
  • MammaPrint testing before initiation of adjuvant therapy.

排除标准

  • Incomplete medical history.
  • Pregnancy or lactation.
  • Contradiction of chemotherapy or ovarian function suppression.

结局指标

主要结局

Treatment decision survey

时间窗: 6 weeks

Treatment decision change after MammaPrint testing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Biyun Wang, MD

Professor

Fudan University

研究点 (1)

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