EUCTR2010-021220-10-FR进行中（未招募）不适用
A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Both Safety Run In and Phase II portion:
- •1. Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
- •2. Histological confirmation of breast cancer, with documented positive oestrogen receptor status (ER+)
- •3 Fulfils specific criteria for previous treatment of breast cancer:
- •a.Relapsing during, or within 12 months of completion of, a single regimen of adjuvant endocrine therapy with non-steroidal AI and/or tamoxifen OR
- •b. Progression following first line endocrine therapy with a non-steroidal AI and/or tamoxifen for advanced breast cancer
- •Randomised phase IIa portion only:
- •1. Mandatory provision of tumour biopsy for AZ approved laboratory confirmation of FGFR1 polysomy or gene amplification
- •2. At least one measurable lesion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than one regimen of endocrine therapy for advanced breast cancer
- •2. Previous exposure to exemestane or any agent known to inhibit FGFRs
- •3. Any prior chemotherapy for advanced breast cancer
- •4. Abnormal cardiac function
- •5. Any evidence of severe or uncontrolled systemic diseases
- •6. Inadequate bone marrow reserve or organ function
- •7. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
研究者
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