Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT01956552
- Lead Sponsor
- Institut Curie
- Brief Summary
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 130
To be eligible to participate in the study, patients must fulfill all of the following criteria:
Female patients. Age ≥ 18 years. ECOG performance status ≤ 2. Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse.
Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes).
Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure).
Social and psychological welfare in concordance with compliance to the study.
To be eligible to participate in the study, patients must fulfill none of the following criteria:
Bilateral or multifocal breast cancer. Isolated local or contralateral relapse.
Solitary bone and/or brain metastatic disease unless :
Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression. 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Centre Oscar Lambret
🇫🇷Lille, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Curie
🇫🇷Paris, France
Institut Curie HOPITAL RENE HUGUENIN
🇫🇷Saint-cloud, France
Hopital Saint Louis
🇫🇷Paris, France
INSTITUT DE CANCEROLOGIE DE L'OUEST René Gauducheau
🇫🇷Saint-Herblain, France