NCT02094742

Brief Summary

This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
4 countries

4 active sites

Status
completed

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

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

March 4, 2014

Last Update Submit

October 14, 2014

Conditions

Metastatic Breast Cancer

Keywords

screening programmetastatic breast cancermolecular profilegene sequencing

Outcome Measures

Primary Outcomes (1)

  • molecular screening program feasibility

    To evaluate the feasibility of implementing a molecular screening program in order to identify molecular traits in patients that may render them eligible for clinical trials using specific targeted agents.

    6 months after end of recruitment

Secondary Outcomes (6)

  • concordance of targeted gene mutation testing by different technologies

    6 months after end of recruitment

  • number of patients with potential "actionable" mutations

    6 months after end of recruitment

  • proportion of core biopsy specimens from invasive recurrent or metastatic lesions

    6 months after end of recruitment

  • technical failure rate (FR)

    6 months after end of recruitment

  • ability of the MSPP (IT platform) to sort patients to several simulated protocols

    6 months after end of recruitment

  • +1 more secondary outcomes

Study Arms (1)

all-commers

OTHER

All patients will undergo a biopsy of their metastatic lesion and have a blood sample taken for molecular screening purposes. No drugs are administered or other interventions are performed.

Procedure: biopsy

Interventions

biopsyPROCEDURE
all-commers

Eligibility Criteria

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

You may qualify if:

  • Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
  • Age ≥ 18 years.
  • Histologically proven metastatic or locally recurrent invasive breast cancer.
  • Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.

You may not qualify if:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status \>2.
  • The biopsy procedure is estimated to be too risky for the patient.
  • Any bevacizumab treatment administered less than 3 weeks before new biopsy procedure.
  • No appropriate wash-out period for patients on anticoagulation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Klinikum Offenbach

Offenbach, Frankfurt, Germany

Location

Val d'Hebron

Barcelona, Spain

Location

University Hospital

Dundee, United Kingdom

Location

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

  • Sherene Loi, MD, PhD

    Institut Jules Bordet, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

  • Christos Sotiriou, MD, PhD

    Institut Jules Bordet, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

  • Martine Piccart, MD, PhD

    Institut Jules Bordet, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 24, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-03

Locations

GB(1)DE(1)ES(1)BE(1)