EUCTR2008-000579-12-IT进行中（未招募）1 期
A randomised, double-blind, parallel-group, multicentre, phase ii study to evaluate the safety and pharmacological activity of the combination of Vandetanib (100 or 300 mg/daily or placebo) with Fulvestrant (loading dose), in postmenopausal advanced breast cancer patients - ZACFAST
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 41
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
- •1. Written informed consent
- •2. Post menopausal woman, defined as a woman fulfilling any 1 of the following
- •3. Histologically or cytologically confirmed carcinoma of the breast
- •4. Patients with metastatic or locally advanced disease not amenable to therapy with
- •curative intent
- •5. Patients may have either measurable or non-measurable disease, as defined by
- •RECIST criteria
- •6. Must have estrogen receptor ER + and/or progesterone receptor PR+ on primary or
- •secondary tumour
- •7. Either patients relapsing during adjuvant treatment or patients presenting with
- •locally advanced or metastatic breast cancer
- •8. One previous chemotherapy for advanced disease is allowed (patients who have
- •stable but evident disease after chemotherapy are eligible)
- •9. One previous hormone therapy for advanced disease is allowed
- •10. Neoadjuvant or adjuvant therapy for breast cancer is allowed
- •11. Patients must have an ECOG PS < 2 and a life expectancy of at least 12 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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. Hormone receptor negative tumours (ER and PgR negative)
- •2. Prior therapy with fulvestrant or prior treatment with VEGFR TKIs (previous
- •treatment with bevacizumab [Avastin] is permitted)
- •3. More than one previous hormone-therapy for the advanced disease as defined
- •4. More than one previous chemo-therapy for the advanced disease as defined before
- •5. CNS metastases
- •6. Presence of life-threatening metastatic visceral disease, defined as extensive
- •hepaticinvolvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete
- •pulmonary parenchymal metastases are eligible, provided their respiratory function
- •is not clinically and significantly compromised as a result of disease
研究者
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