Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.
详细描述
OBJECTIVES:
- Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI following treatment.
- Identify those cellular antigens which are altered by hormonal therapy.
- Determine which cellular antigens are predictive of clinical response to hormonal therapy.
- Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment.
OUTLINE: This is a pilot study.
Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity.
After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
干预措施: conventional surgery (Procedure)
tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
干预措施: letrozole (Drug)
tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
干预措施: tamoxifen citrate (Drug)
tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
干预措施: neoadjuvant therapy (Procedure)
结局指标
主要结局
Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography
时间窗: Baseline and 6 months
Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes
Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI)
时间窗: Baseline and 6 months
Change in size of Ductal Carcinoma in situ (DCIS) on hormonal therapy, as determined by MRI are determined by (1) largest diameter of tumor, as visualized on MRI (2) extent of disease on MRI (3) quantification of MR-detected change from baseline to 6-month and used to generate the change in tumor volume of MRI extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes.
次要结局
- Number of Responders to Neoadjuvant Therapy at Month 3(3 months)
- Number of Responders to Neoadjuvant Therapy at Month 6(6 months)
- Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group(Baseline and 6 months)
- Median Reduction in Tumor Volume by PgR H-score by Quartile Group(Baseline and 6 months)
- Median Reduction in Tumor Volume by Ki-67 Average Score(Baseline and 6 months)
- Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size(6 months)
- Correlation Between Pathologic Tumor Size and Mammographic Tumor Size(6 months)