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

I

Institut Curie

Status

Terminated

Conditions

Metastatic Breast Cancer

Treatments

Other: biopsy or cytopuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01956552
IC 2009-05

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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