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SHORTened Duration of TAMoxifen

2026年9月1日 更新者:Mridula George, MD、Rutgers, The State University of New Jersey

SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women

The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for breast cancer.

研究概览

详细说明

The patients to be entered in this protocol will be post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical ductal hyperplasia, and atypical lobular hyperplasia (ALH) OR post-menopausal women with an elevated 5-year Gail model risk (> 1.66%) but with no prior history of breast intraepithelial or invasive cancers

Potential subjects will be recruited by the treating investigator and approached to participate in the study during consultation for the treatment and management of their disease as an alternative treatment option.

Subjects from all racial/ethnic groups are eligible for this study if they meet the eligibility criteria

研究类型

介入性

注册 (估计的)

250

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Rutgers Cancer Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 1. Patient at high risk for invasive breast cancer (either A or B)

A. Post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), Lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), and atypical lobular hyperplasia (ALH) who meet the following criteria:

  • DCIS/LCIS

    • Lesion size ≤3cm
    • Low or intermediate grade
    • Lesion completely excised by surgical excision
    • Margins >2cm for DCIS
    • Estrogen receptor (ER) positive and/or Progesterone receptor positive (defined as ≥10%)
  • ADH/ALH o Lesion completely excised by surgical excision

B. Patients at increased risk of breast cancer based on Gail model criteria (5- year risk ≥1.66%) without prior history of DCIS, LCIS, atypical hyperplasia, or invasive breast cancer.

2. No history of pathogenic germline mutations that increase the lifetime risk of breast cancer. If genetic testing was not done, then patients must have no more than two first-degree relatives diagnosed with breast cancer.

3. Should have received adjuvant radiation for DCIS, if recommended by the radiation oncologist.

4. No prior history of invasive carcinoma, DCIS, LCIS, ADH, and/or ALH in bilateral breasts.

5. ECOG performance status ≤ 2 6. No use of hormone replacement therapy for at least 5 years.

Exclusion Criteria:

  1. Evidence of invasive or microinvasive breast cancer.
  2. Current use of dicumarols and CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors.
  3. Patients who have had a bilateral mastectomy for risk reduction.
  4. Prior history of any malignancy in the last 5 years (except squamous cell carcinoma/basal cell carcinoma of skin)
  5. Patients who are known to be pregnant
  6. Patients who cannot voluntarily provide informed consent. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
  7. Life expectancy of less than 1 year per treating physician.
  8. Prior treatment with tamoxifen or an aromatase inhibitor.

    -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Low dose Tamoxifen
Low-dose tamoxifen will be administered at 10 mg orally every other day for 18 months.
Low dose Tamoxifen for 18 months.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Low Dose Tamoxifen
大体时间:18 Months
To evaluate the efficacy of a de-escalated, 18-month regimen of low-dose tamoxifen (10 mg every other day) in reducing the risk of disease recurrence or invasive breast cancer in post-menopausal women with breast intraepithelial neoplasia or an elevated 5-year Gail model risk.
18 Months

次要结果测量

结果测量
措施说明
大体时间
Evaluation of Tamoxifen Tolerability
大体时间:18 months
Incidence of endometrial cancer or thromembolic events.
18 months
To evaluate the Incidence of other invasive events
大体时间:18 months
Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast.
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mridula George, MD、Rutgers Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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