NCT01004081已完成2 期
Phase 2a, Open-Label, Randomized, Noncomparative Study of BIIB021 in Combination With Exemestane in Women With Hormone Receptor-Positive, Advanced Metastatic Breast Cancer Who Have Progressed on a Nonsteroidal Aromatase Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years of age
- •Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
- •Must have disease progression during treatment with a nonsteroidal AI for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
- •Must be a postmenopausal female.
- •Must have measurable or evaluable disease.
- •Measurable disease is defined as >=1 lesion with a diameter of >=10 mm
- •Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan, or MRI. Lesions identified only by radionuclide bone scan are not allowed.
- •One prior chemotherapy regimen for advanced mBC is allowed.
- •Prior radiotherapy is allowed.
- •Must be able to swallow and retain oral medication.
- •ECOG performance status of <=2
- •Required laboratory values
- •Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
排除标准
- •HER2 overexpressing tumor.
- •History of central nervous system (CNS) metastasis.
- •Previous treatment with exemestane or treatment with an Hsp90 inhibitor.
- •Use of proton pump inhibitors.
- •Known history of or positive test result for hepatitis B or C or HIV.
- •History of gastrectomy or major surgery to small intestine.
研究组 & 干预措施
BIIB021 BID + exemestane
Experimental
BIIB021 100 mg BID + exemestane 25 mg QD
干预措施: BIIB021 (Drug)
BIIB021 BID + exemestane
Experimental
BIIB021 100 mg BID + exemestane 25 mg QD
干预措施: exemestane (Aromasin) (Drug)
BIIB021 TIW + exemestane
Experimental
BIIB021 450 mg TIW + exemestane 25 mg QD
干预措施: BIIB021 (Drug)
BIIB021 TIW + exemestane
Experimental
BIIB021 450 mg TIW + exemestane 25 mg QD
干预措施: exemestane (Aromasin) (Drug)
结局指标
主要结局
The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
时间窗: As specified in protocol
次要结局
- The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.(As specified in protocol)
研究者
研究点 (1)
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