A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 19
- 主要终点
- Progression Free Survival (PFS) Based on Local Investigator Assessment
研究概览
简要总结
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.
Patients must undergo molecular pre-screening prior to entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer
- •Progression on or after endocrine treatment
- •Measureable disease as per RECIST
- •ECOG 0, 1 or 2
排除标准
- •Evidence of CNS or leptomeningeal metastases
- •Previous treatment with fulvestrant
- •Previous chemotherapy for locally advanced or metastatic breast cancer
- •Cirrhosis or chronic active/persistent hepatitis
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fulvestrant + Dovitinib active
Fulvestrant in combination with the study drug Dovitinib.
干预措施: Dovitinib (Drug)
Fulvestrant + Dovitinib active
Fulvestrant in combination with the study drug Dovitinib.
干预措施: Fulvestrant (Drug)
Fulvestrant + Dovitinib placebo
Fulvestrant in combination with a placebo matching Dovitinib.
干预措施: Fulvestrant (Drug)
Fulvestrant + Dovitinib placebo
Fulvestrant in combination with a placebo matching Dovitinib.
干预措施: Dovitinib Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Based on Local Investigator Assessment
时间窗: Every 8 weeks assessed up to 34 months
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.
次要结局
- Number of Participants With Adverse Events as a Measure of Safety(Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months))
- Overall Response Rate (ORR)(Every 8 weeks assessed up to 34 months)
- Duration of Response (DOR)(From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months)
- Time to Worsening of ECOG Performance Status(Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months))
- Overall Survival (OS) Using Kaplan- Meier Method(From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months)