A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Determine Tumor Objective Response (OR) Rates
研究概览
简要总结
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed breast cancer which is metastatic.
- •A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
- •Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
- •Patients must have measurable disease.
- •Eastern Cooperative Oncology Group performance status 0-
- •Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
- •Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
- •Age >18 years
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function as defined below:
排除标准
- •systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
- •Patients receiving any other investigational agents for breast cancer treatment.
- •Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
- •Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
- •Dysfunctional or post-menopausal vaginal bleeding.
- •Uncontrolled hypercalcemia/hypocalcemia
- •Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
- •History of or active hepatic adenoma.
- •Uncontrolled intercurrent illness
- •Pregnant women are excluded from this study
- •Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.
研究组 & 干预措施
Estrogen Therapy
Estrogen therapy
干预措施: Estradiol (Drug)
结局指标
主要结局
Determine Tumor Objective Response (OR) Rates
时间窗: Up to 4 years
OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Clinical Benefit (CB)(Up to 4 years)
- Progression-free Survival (PFS)(Up to 4 years)
- Median Overall Survival (OS)(Up to 4 years)