on-invasive monitoring of breast cancer therapy using circulating tumor DNA from peripheral blood - NAVIGATOR

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Age >=18 years
•Postmenopausal status, being defined as:
•- Age >=60 years
•- Age <60 years and last menstruation >=1 year ago when not treated with chemotherapy and/or endocrine treatment in the meantime
•- Age <60 years and postmenopausal luteinizing hormone (LH), follicle stimulating hormone (FSH), and plasma estradiol levels
•- Surgical or radiation-induced sterilization
•Histologically or cytologically confirmed diagnosis of metastatic breast cancer
•Histological confirmation of ER-positive (>10% of the tumor cells ER-positive), HER2-negative disease (1+ staining or 2+ non-amplified), preferentially of the primary tumor, but otherwise of a biopsied metastatic/recurrent site
•Radiologically evaluable disease according to RECIST version 1.1
•Willingness and capacity to follow the protocol specified visits for blood sampling for the total duration of the study
•Capacity of understanding and signing the informed consent brochure prior to the blood samplin

•Prior treatment in the metastatic setting with any AI
•For the second part of blood sampling during everolimus/exemestane: other hormonal treatment in between the AI and combination everolimus/exemestane line. Chemotherapy to contain rapidly progressing before starting everolimus/exemestane is allowed.
•A secondary malignancy currently present or curatively treated within the last five years before registration, except for non-melanoma skin cancer, cervical carcinoma in situ, or bladder cancer in situ.

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