NCT00080613撤回2 期
Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Robert H. Lurie Cancer Center2 个研究点 分布在 1 个国家开始时间: 2004年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
研究概览
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed breast cancer
- •Locally advanced disease (stage II or III)
- •Not amenable to breast-conserving therapy at the time of diagnosis
- •Measurable disease meeting 1 of the following criteria:
- •Bidimensionally measurable palpable lesion at least 1 cm by caliper
- •Unidimensionally measurable lesion at least 1 cm by a positive mammogram, ultrasound, or MRI
- •No evidence of disease outside the breast or chest wall except ipsilateral axillary lymph nodes
- •Hormone receptor status:
- •Estrogen and/or progesterone receptor positive
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •Menopausal status
- •Postmenopausal, defined as any of the following:
- •Over 60 years of age
- •Over 45 years of age with an intact uterus and amenorrhea for more than 12 months
- •Prior hysterectomy with follicle-stimulating hormone levels within the postmenopausal range
- •Prior ovarian ablation (i.e., bilateral surgical)
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Creatinine less than 2 mg/dL
- •No other prior or concurrent cancer except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for breast cancer
- •Chemotherapy
- •No prior chemotherapy for breast cancer
- •Endocrine therapy
- •No prior hormonal therapy for breast cancer
- •Radiotherapy
- •No prior radiotherapy for breast cancer
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In SituBreast CancerNCT00072462Queen Mary University of London2,980
已完成
3 期
Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast CancerBreast CancerNCT00002777European Organisation for Research and Treatment of Cancer - EORTC342
Unknown
3 期
Adjuvant Hormone Therapy in Treating Women With Operable Breast CancerBreast CancerNCT00002460Cancer Research UK
Unknown
1 期
High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or MesotheliomaEndometrial CancerMalignant MesotheliomaBreast CancerNCT00002465St. Vincent Medical Center - Los Angeles
已完成
3 期
Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast CancerBreast CancerNCT00002529ETOP IBCSG Partners Foundation452