An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 carcinoma of the breast with locally advanced or metastatic disease
- •Confirmation of hormone receptor (HR) positive disease status
- •Amenable to receive endocrine therapy
- •Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer
- •Postmenopausal woman ≥ 18 years old
排除标准
- •HR-unknown or HR-negative disease
- •Not amenable to endocrine therapy
- •Central nervous system metastasis
研究组 & 干预措施
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
干预措施: AMG 479 (Drug)
Arm B: placebo IV Q2W + Endocrine Therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
次要结局
- Number of Participants With Adverse Events(30 days after the last dose of study treatment, up to 109 weeks)
- Cmax of AMG 479(Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.)
- Clinical Benefit and Objective Response Rate(Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.)
- Duration of Response and Time-to-response(Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.)
- Time To Progression, Time-to-treatment Failure, Overall Survival(Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.)
- Global Health Status Time-Adjusted AUC(From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days.)