NCT03619044终止不适用
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 12
- 主要终点
- The rate of patients with conversion of FES negative lesions in FES positive lesions.
研究概览
简要总结
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).
Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.
Patients will be followed during the 3 cycles of treatment.
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
- 否
入选标准
- •Age ≥ 18 years.
- •Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
- •Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
- •Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
- •For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
- •Patient affiliated to a Social Health Insurance in France.
- •Patient must provide written informed consent prior to any study specific procedures.
排除标准
- •Any previous treatment for metastatic disease.
- •Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
- •Patient with isolated hepatic metastasis.
- •Patient with hemostasis disorders.
- •Unbalanced Diabetes.
- •Patient with usual formal contraindication to PET/TDM Imaging.
- •Patient who has already started trastuzumab + pertuzumab + taxane treatment.
- •Pregnant or breastfeeding women.
- •Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
- •Patient protected by law.
结局指标
主要结局
The rate of patients with conversion of FES negative lesions in FES positive lesions.
时间窗: Cycle 3 Day 1 for each patient.
次要结局
- The rate of patients with FES positive lesions before treatment.(Cycle 4 Day 1 for each patient.)
- The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.(Cycle 4 Day 1 for each patient.)
研究者
研究点 (12)
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