NCT01956552

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

6.1 years

First QC Date

September 26, 2013

Last Update Submit

January 29, 2024

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancerTumor biopsyPhenotype and genotype characterization

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

biopsy or cytopunctureOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Oscar Lambret

Lille, 59020, France

Location

Hopital Saint Louis

Paris, 75004, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Curie HOPITAL RENE HUGUENIN

Saint-Cloud, 92210, France

Location

INSTITUT DE CANCEROLOGIE DE L'OUEST René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 33722295DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • SIGAL BRIGITTE, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 8, 2013

Study Start

November 1, 2009

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(6)