EUCTR2010-021220-10-HU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 Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW) - GLOW
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
- •Histological confirmation of Breast Cancer with documented ER+ receptor status
- •Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AI
- •Randomised phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
- •Randomised phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification
- •At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
- •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
- •Prior exposure to exemestane (safety run-in) / fulvestrant (randomised phase IIa), or any agent known to inhibit FGFRs.
- •More than 1 prior regimen of chemotherapy for breast cancer
- •ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
- •History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomised phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
- •Randomised phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
研究者
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