Intermittent Exemestane Therapy for Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal women with stage IV breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. Progression-free survival at 4 months, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
SECONDARY OBJECTIVES:
I. Objective response rate (complete response [CR] and partial response [PR]).
II. Clinical benefit (CR, PR, and stable disease >= 6 months).
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 metastatic carcinoma of the breast
- •Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue
- •Postmenopausal, as defined by any of the following:
- •Natural menopause, with at least 1 year since last menses
- •Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- •History of surgical or radiation-induced ovarian ablation
- •For women =< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range
- •Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy
- •Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)
- •Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Neutrophil count >= 1.5 X 10^9 cells/L
- •Platelet count >= 100 X 10^9 cells/L
- •Serum creatinine =< 1.5 times upper limit of normal (ULN)
- •Total serum bilirubin =< 1.5 times ULN
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases
- •Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases
- •Subjects must have an estimated life expectancy of greater than 6 months
排除标准
- •Prior exposure to EXE, whether in the adjuvant or metastatic setting
- •Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix
- •Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)
- •Hormone-receptor negative or unknown breast cancer
- •More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)
- •Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases
- •Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted
- •Subjects who have had no prior exposure to endocrine therapy
- •Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures
研究组 & 干预措施
Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: exemestane (Drug)
Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: immunohistochemistry staining method (Other)
结局指标
主要结局
Progression-free Survival
时间窗: Until disease progression of death from any cause, up to 3 years
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Overall Response Rate(Until disease progression or off treatment, assessed up to 1 year)