2024-513934-40-00招募中2 期
Clinical utility of a next generation sequencing-based “oncochip” for therapeutic decision in metastatic breast cancer. Study SHARP
Istituto Europeo Di Oncologia S.r.l.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年11月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- progression free-survival
研究概览
简要总结
To compare progression-free-survival in the experimental group compared to standard chemotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form.
- •Life expectancy =3 months
- •For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug.
- •Ability to swallow oral capsules
- •Ecocardiogramma normale al baseline ( LVEF >50% e SF >15%)
- •Patients with histologically confirmed breast adenocarcinoma.
- •Patients with documented presence of specific molecular alterations.
- •Patient has radiologic evidence of inoperable locally advanced, or metastatic BC
- •Presence of measurable lesions according to RECIST criteria v1.
- •Lytic bone lesions or mixed lytic-blastic lesions , that can be evaluated by MRI , can be considered as measurable lesions.
- •Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier. For patients with only bone lesions the biopsy is not mandatory but an available tumor sample (including primitive tumor) is requested
- •Age > 18 years
- •Patients should have documented disease progression. There are not limits to previous systemic anticancer therapy for the metastatic or locally recurrent disease. Patients with HER2+ disease must have received 2 or more line of antiHER2 treatment (including dual blockade with pertuzumab/trastuzumab and T-DM1 or other anti HER2 agents that my impact OS).
排除标准
- •Patients with known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti-convulsant medications for at least 2 weeks prior to the first dose of study medication.
- •History of clinically significant or uncontrolled cardiac disease
- •Uncontrolled arterial hypertension
- •Participation in another clinical study with an investigational product (IP) during the last 30 days
结局指标
主要结局
progression free-survival
progression free-survival
次要结局
- Overall survival
研究者
Giuseppe Curigliano
Scientific
Istituto Europeo Di Oncologia S.r.l.
研究点 (1)
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