Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
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Keep this study
Lead
Institut Curie
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2
A least one metastatic site and/or inoperable loco-regional relapse
Measurable disease (RECIST v1.1)
Age from 18 to 75 years
Performance status of 0-2
Efficient contraceptive in non-menopause women
At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC
Performance status of 0-2
Adequate cardiac function
Adequate hematological and biochemical blood tests
You may not be if
Life expectancy of less than 3 months
Previous history of any other stage III or IV invasive cancer
Male breast cancer
Uncontrolled brain metastases
Significant cumulated exposure to anthracyclines
Current or previous significant history of cardio-vascular/pulmonary disease
Previous use of trastuzumab
Clareo Health | Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.