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临床试验/NCT04129216
NCT04129216已完成2 期

The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)

研究概览

简要总结

The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

详细描述

Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Tamoxifen arm

Experimental

for premenopausal patients

干预措施: Tamoxifen Citrate (Drug)

Tamoxifen arm

Experimental

for premenopausal patients

干预措施: Blueprint (Diagnostic Test)

Tamoxifen arm

Experimental

for premenopausal patients

干预措施: Mammaprint (Diagnostic Test)

Letrozole arm

Experimental

for postmenopausal patients

干预措施: Letrozole (Drug)

Letrozole arm

Experimental

for postmenopausal patients

干预措施: Blueprint (Diagnostic Test)

Letrozole arm

Experimental

for postmenopausal patients

干预措施: Mammaprint (Diagnostic Test)

Exemestane arm

Experimental

for postmenopausal patients

干预措施: Exemestane (Drug)

Exemestane arm

Experimental

for postmenopausal patients

干预措施: Blueprint (Diagnostic Test)

Exemestane arm

Experimental

for postmenopausal patients

干预措施: Mammaprint (Diagnostic Test)

结局指标

主要结局

Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)

时间窗: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy

This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.

次要结局

  • Median Percent of Tissue PR Positive(Baseline and at Time of surgery (up to 6 weeks))
  • Median Percent of Tissue ER Positive(Baseline and at Time of surgery (up to 6 weeks))
  • Number of Participants With Low or High Score in MammaPrint(Baseline and at Time of surgery (up to 6 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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