Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting

Institut Curie6 sites in 1 country130 target enrollmentNovember 2009

ConditionsMetastatic Breast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Metastatic Breast Cancer
Sponsor: Institut Curie
Enrollment: 130
Locations: 6
Primary Endpoint: To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

February 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut Curie

Responsible Party

Sponsor

Eligibility Criteria

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 ≤
•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.

Outcomes

Primary Outcomes

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