A Single Arm Phase IIa Study (With Combination SRI) to Assess the Safety & Efficacy of AZD4547 in Combination With Either Anastrozole or Letrozole in ER+ Breast Cancer Patients Who Have Progressed on Treatment With Anastrozole or Letrozole
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Proportion of Tumour Size Change at 12 Weeks (or Progression if Prior to Week 12)
研究概览
简要总结
This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.
The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)
详细描述
The study will be carried out in two stages. Stage 1 is to find a suitable dose of AZD4547 which can be used together with a class of drugs called nonsteroidal aromatase inhibitors (e.g. anastrozole or letrozole) i.e. a dose which does not cause too many unacceptable side effects.
Patients with hormone sensitive (oestrogen receptor positive) breast cancer, whose current treatment with anastrozole or letrozole has recently stopped working properly will be eligible for this stage.
Stage 2 will then assess the efficacy of AZD4547, based on the change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in patients with hormone sensitive (oestrogen receptor positive) breast cancer, who have progressed on treatment with either anastrozole or letrozole in any setting.
In both stages, the study will look at how well the new treatment is tolerated.
Each patient is only allowed to take part in either stage 1 or 2.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm study
NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily but together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
干预措施: AZD4547 / anastrozole or letrozole (Drug)
结局指标
主要结局
Proportion of Tumour Size Change at 12 Weeks (or Progression if Prior to Week 12)
时间窗: 12 weeks
This is the primary outcome measure in the Randomised Phase IIa part of the study. This is the proportion of tumour size change from baseline to week 12 (or progression if prior to week 12) based on local review of results.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Dose limiting toxicity (DLT) assessment window - days 1 to 28 of cycle 1
Safety and tolerability of AZD4547 to be used in combination with a standard dose of anastrozole or letrozole, as assessed by Dose limiting toxicity (DLT) This is the primary outcome measure in the Safety Run-In part of the study.
次要结局
- Progression Free Survival(42 months)
- Proportion of Tumour Size Change at 6, 20 and 28 Weeks(6, 20 and 28 weeks)
- Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks(6, 12, 20 and 28 weeks)
- Objective Response at 6, 12, 20 and 28 Weeks(6, 12, 20 and 28 weeks)