NCT00767520已完成2 期
A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 155 人开始时间: 2009年2月最近更新:
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
- 入组人数
- 155
- 试验地点
- 5
- 主要终点
- Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
研究概览
简要总结
The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis
- •Prior therapy with a non-steroidal aromatase inhibitor
- •Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)
- •Documented breast cancer with tumor ≤ 28 days prior to study entry
- •Women who are NOT of childbearing potential
- •Must be able to take oral medication
- •Performance Status 0 or 1
排除标准
- •Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry
- •Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI
- •Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry
- •Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer
- •Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years
- •Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding
- •Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)
- •Hematologic abnormality Grade ≥ 2
- •Hypocalcemia of Grade ≥ 1
- •Any Chemistry abnormality of Grade ≥ 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]
- •Pregnant Women and Women of Childbearing Potential (WOCBP)
- •Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)
- •Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)
- •Potent inhibitors of CYP3A4 isoenzyme
- •Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
研究组 & 干预措施
A
Active Comparator
干预措施: Exemestane + Dasatinib (Drug)
B
Placebo Comparator
干预措施: Exemestane + Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
时间窗: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)
PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer \& Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
时间窗: Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)
PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
次要结局
- Number of Participants With Best Overall Response(at 6 months)
- Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months(at 6 months)
- Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms(Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks))
- Participants With Freedom-From-Progression (FFP) at 6 Months(at 6 months)
- Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms(Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer)
- Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms(Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.)
- Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis(Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.)
- Changes in Markers of Bone Lysis in Participants With Bone Metastasis(Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.)
- Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)(From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.)
- Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)(Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.)
- Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)(Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.)
- Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)(Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.)
- Number of Participants With Abnormalities in Vital Signs(Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.)
- Number of Participants With Abnormalities in Electrocardiograms(Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.)
研究者
研究点 (5)
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