EUCTR2010-021220-10-DE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 EGFR Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic). (GLOW) - GLOW
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 89
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+
- •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
- •b) Progression following first line endocrine therapy with a non-steroidal AI for advanced breast cancer. Co-administration of a targeted agent with the non-steroidal AI is permitted providing all toxicities have recovered to a CTCAE Grade 1 or below.
- •Randomised phase IIa: Mandatory provision of tumour biopsy for AstraZeneca approved laboratory confirmation of FGFR1 polysomy or gene amplification (FISH score 4 or more)
- •Randomised IIa: At least one measurable lesion that can be accurately assessed by CT/MRI 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
- •More than one regimen of endocrine therapy for advanced breast cancer
- •Safety Run-in: More than 1 prior regimen of chemo therapy
- •Randomised IIa: Any prior chemotherapy for advanced breast cancer
- •ECG recordings that demonstrate abnormalities in rhythm and function
- •A history of a bad reaction to AZD4547 or exemestane or medications similar in class or structure
研究者
相似试验
进行中（未招募）
不适用
Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patientsER+ Breast cancerMedDRA version: 16.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021220-10-HUAstraZeneca AB120
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). - NDBreast CancerEUCTR2010-021220-10-ITASTRAZENECA72
进行中（未招募）
不适用
Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patientsER+ Breast cancerMedDRA version: 15.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021220-10-GBAstraZeneca AB120
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)MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancerBreast CancerEUCTR2010-021220-10-FRAstraZeneca AB72
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)Breast CancerEUCTR2010-021220-10-CZAstraZeneca AB72