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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT01956552 |
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Date of registration:
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26/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)
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Scientific title:
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Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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130 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01956552 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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SIGAL BRIGITTE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Other: biopsy or cytopuncture
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Primary Outcome(s)
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To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
[Time Frame: 2 years]
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Secondary ID(s)
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IC 2009-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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