NCT00126464Unknown不适用
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.
详细描述
OBJECTIVES:
Primary
- Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast.
Secondary
- Determine the toxicity profile of fulvestrant in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
- •T0 disease
- •Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool [mammotome] or an equivalent method)
- •Biopsy tissue available for molecular marker analysis
- •Baseline mammography performed within the past 8 weeks
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •Menopausal status
- •Postmenopausal, as defined by 1 of the following:
- •Age ≥ 45 AND amenorrheic for > 1 year with uterus intact
- •Underwent bilateral oophorectomy
- •Follicle-stimulating hormone and estradiol levels in postmenopausal range
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Bilirubin ≤ 2.0 times ULN
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No history of deep vein thrombosis
- •No history of pulmonary embolism
- •Negative pregnancy test (if clinically indicated)
- •No peripheral neuropathy > grade 1
- •No underlying medical, psychiatric, or social condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •More than 6 months since prior hormonal therapy, including any of the following:
- •Antiestrogens
- •Selective estrogen-receptor modulators
- •Progestins
- •Aromatase inhibitors
- •Radiotherapy
- •Not specified
- •Not specified
- •No prior therapy for DCIS
排除标准
- 未提供
结局指标
主要结局
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
次要结局
- Mammographic breast density as measured by the Madena method at 3 weeks
研究者
研究点 (1)
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