Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Stage II Breast Cancer
- 发起方
- Robert H. Lurie Cancer Center
- 试验地点
- 1
- 状态
- 撤回
- 最后更新
- 12年前
概览
简要总结
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen and/or progesterone receptor-positive breast cancer.
详细描述
OBJECTIVES: Primary * Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane. Secondary * Determine the response rate by mammography, ultrasound, MRI, and positron emission tomography scan in patients treated with this drug. * Determine the time to progression in patients treated with this drug. * Compare the expression of hormone receptors and epidermal growth factor receptors (including HER2/neu) in patients prior to and after treatment with this drug and correlate these results with clinical response rates. OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then continue exemestane once daily for a total of 5 years (including the 16 weeks before surgery). Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
未指定