Clinical trial NCT01956552: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)
Official title: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Tumor biopsy
Phenotype and genotype characterization
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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 ≤ 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.

Primary outcomes:
measure: To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Institut Curie
city: Saint-cloud
country: France
facility: Institut Curie HOPITAL RENE HUGUENIN
city: Saint-Herblain
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST René Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Curie
name: SIGAL BRIGITTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callens C, Driouch K, Boulai A, Tariq Z, Comte A, Berger F, Belin L, Bieche I, Servois V, Legoix P, Bernard V, Baulande S, Chemlali W, Bidard FC, Fourchotte V, Salomon AV, Brain E, Lidereau R, Bachelot T, Saghatchian M, Campone M, Giacchetti S, Zafrani BS, Cottu P. Molecular features of untreated breast cancer and initial metastatic event inform clinical decision-making and predict outcome: long-term results of ESOPE, a single-arm prospective multicenter study. Genome Med. 2021 Mar 15;13(1):44. doi: 10.1186/s13073-021-00862-6.