A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Measure change in size of DCIS on routine imaging
研究概览
简要总结
The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.
详细描述
The overarching hypothesis of our research is that black cohosh has potential to be a well-tolerated, effective agent for the treatment of early breast cancer. This pilot study represents a first step in exploring this hypothesis by demonstrating preliminary evidence of specific anti-tumor effect of black cohosh on areas of ductal carcinoma in situ (DCIS) in the breast.
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
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
- •Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy
- •Ability to understand and the willingness to sign a written informed consent document
- •ECOG performance status 0-1
- •Life expectancy >12 months
- •Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment
- •Original breast core biopsy specimen available for pathologic review and staining by Yale School of Medicine Department of Pathology
排除标准
- •A patient /subject will not be eligible for this study if any of the following exclusion criteria are met:
- •Pregnant or nursing within past 6 months
- •Lactose intolerant, lactose allergy or salicylate allergy
- •Patients who have already undergone excisional biopsy for qualifying DCIS
- •Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
- •Patients receiving any other chemotherapy or investigational agents
- •Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- •Liver function tests ≥ 20% of the institutional upper limits of normal
- •Creatinine > 1.5 times the institutional upper limit of normal
- •ANC < 1,500 /µL
- •Platelets < 100,000 /µL
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
- •The effects of black cohosh on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Prior/concurrent therapy including:
- •Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months
- •Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin®]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
- •Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
- •Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
- •Any black cohosh preparation within the past 6 months
结局指标
主要结局
Measure change in size of DCIS on routine imaging
时间窗: 4 weeks
1. Measure change in size of DCIS on routine imaging (i.e. mammography and/or ultrasound) obtained before and after 4 weeks of treatment with black cohosh, with correlation to specimen sizes; and 2. Determine differences in breast epithelial cell proliferation in areas of DCIS as measured by mean change in levels of Ki67 before and after 4 weeks of treatment with black cohosh. Ki67 levels will be assessed with traditional immunohistochemical staining as well as AQUA technology.
次要结局
- Assess adherence to a brief course of black cohosh.(4 weeks)
- Assess safety and side effects of 4 week course of black cohosh(4 weeks)