Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Frequency of ESR1 mutations
研究概览
简要总结
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.
详细描述
Breast cancer is the most common cancer in woman. Aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists.
ESR1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment.
The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.
The significance of the Digital PCR technique will be determined first in plasma issued from healthy volunteers.
At the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. During their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman aged superior to 18 years old
- •Inform consent signed
- •Metastatic breast cancer or loco-regionnaly advanced breast cancer
- •Inoperable
- •With an indication to treat with aromatase inhibitor
- •Treatment with aromatase inhibitors innitiated at the inclusion or at least 6 months before inclusion with a stable disease
- •Without precedent treatment or with treatment by chemotherapy/tamoxifen/faslodex or aromatase inhibitors in a adjuvant treatment and with a time frame of 2 years between last treatment with aromatase inhibitors and metastatic evolution
- •Treatment by aromatase inhibitors alone or in combination with a targeted therapy (trastuzumab +/- pertuzumab, bevacizumab, everolimus)
排除标准
- •No inform consent signed
- •Patient under guardianship, curatorship
- •Psychosocial disorder
- •No affiliated or beneficiary of a social benefit system
结局指标
主要结局
Frequency of ESR1 mutations
时间窗: up to 24 months
Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease
次要结局
- Frequency of progression without ESR1 mutations(up to 24 months)
- Time between introduction of aromatase inhibitor and detection of ESR1 mutations(up to 24 months)