The use of FES-PET imaging as a tool to detect a possible reversion of Estrogen Receptor (ER)-a status in patients with metastatic breast cancer HER2 + and ERa neg treated with trastuzumab + pertuzumab + taxane. - REVER

INSTITUT CLAUDIUS REGAUD0 个研究点目标入组 33 人开始时间: 2018年7月3日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•1. Age = 18 years.
•2. Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERa neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
•3. Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
•4. Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
•5. OMS = 2.
•6. For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
•7. Patient affiliated to a Social Health Insurance in France.
•8. Patient must provide written informed consent prior to any study specific procedures.
•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 33
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Any previous treatment for metastatic disease.
•2. Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
•3. Patient with isolated hepatic metastasis.
•4. Patient with hemostasis disorders.
•5. Unbalanced Diabètes.
•6. Patient with usual formal contraindication to PET/TDM Imaging.
•7. Patient who has already started trastuzumab + pertuzumab + taxane treatment.
•8. Pregnant or breastfeeding women.
•9. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
•10. Patient protected by law.

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