Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007263

Trial Description

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Title

The BIG Molecular Screening Feasibility Study:Testing the IT Infrastructure and Logistics of a Molecular Screening Program

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Trial Acronym

BIG MS Pilot

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

This study will accept patients with metastatic/recurrent breast cancer disease. The core
biopsies must be taken from a metastatic lesion. To note, these patients can be biopsied at
any phase of their metastatic disease (at diagnosis, at progression etc).

- The patient will sign a specific Informed Consent Form (ICF).

- The Investigator will access the MSPP, register the patient and enter basic patient
clinical data necessary for the verification of the eligibility criteria.

- The patient will prospectively undergo invasive recurrent or metastatic lesions (1 site
easily accessible, such as skin, lymph node or liver) core biopsies including the
collection of tumor samples consisting of 2 Formalin Fixed Paraffin Embedded (FFPE)
Tissues and 1 (2 recommended) fresh frozen samples embedded in Optimal Cutting
Temperature (OCT) compound or stored in RNAlater. One whole blood sample (1x10mL) will
also be collected.

- The Investigator will record the biological samples via the MSPP bio-tracking system

- The Investigator is responsible for the immediate dispatch of the samples to the
designated central laboratories.

- The assays will be performed at the central laboratories. It should be noted that:

- Two FFPE samples will be sent to IEO, Milan, Italy. One FFPE sample will be
stored. The second FFPE will be used to perform pathological tests. The tests
include ER, HER2, Ki67 and PTEN status evaluation by immunohistochemistry (IHC)
and FISH (for HER2 only); and of PIK3CA hot spot somatic mutations identification
by Sanger DNA sequencing. Unstained sections (10x5µm) and extracted DNA, taken
from the FFPE tissue core used for the testing, will be sent to IPG and Sanger,
respectively, by the central laboratory.

- The assays performed at IPG and Sanger will consist of targeted breast cancer
genes mutations identification by Ion Proton or HiSeq 2000 DNA sequencing
respectively. To note, targeted genes screen will also be coupled with
identification of other substitutions, short indels and copy number variants
(CNVs).

- One fresh frozen sample embedded in OCT or stored in RNAlater will be sent to
IJBordet, Brussels, Belgium, together with the blood sample, for Affymetrix gene
expression profiling and for chromosomal and SNP-analysis using the Cytoscan
platform (Affymetrix). The blood sample will be stored.

- The central laboratories will upload the processed data that is generated as a result
of the central testing onto the MSPP.

- An alert, by e-mail, will be sent to the Investigator when the central results are
available. The Investigator will log on to MSPP and obtain the results.

- The residual biological samples and derivatives will be stored in the BIG study
Repository for 15 years or the maximum allowed by local regulations whichever is the
shortest. If needed, remaining material will be used for future research as high
throughput genetic analysis.

It should be noted that the results obtained from the BIG Molecular Screening Feasibility
Study will NOT be used for treatment decision-making. Patients should receive anti-cancer
therapy as per the patient's treating physicians decision and in accordance with local
institutional guidelines. There is no planned follow-up period. The trial will end after all
the information from the 30 accrued patients is entered into the MSPP, within a maximum of 2
months after the recruitment of the last patient.

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Organizational Data

  •   DRKS00007263
  •   2016/02/29
  •   2014/03/04
  •   yes
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Secondary IDs

  •   NCT02094742  (ClinicalTrials.gov)
  •   2012.2  (Jules Bordet Institute)
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Health Condition or Problem studied

  •   Metastatic Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Procedure: biopsy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
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Primary Outcome

- molecular screening program feasibility; time frame: 6 months after end of recruitment; 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.

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Secondary Outcome

- concordance of targeted gene mutation testing by different technologies; time frame: 6 months after end of recruitment; To test the concordance of targeted breast cancer genes mutations testing by different technologies: Life technologies Ion Proton Sequencer (by IPG) versus Illumina Hiseq 2000 (by Sanger).
- number of patients with potential "actionable" mutations; time frame: 6 months after end of recruitment; To evaluate how many of these patients have potential "actionable" mutations that could theoretically render them eligible for the current active targeted trials using FDA approved drugs (as per www.clinicaltrials.gov).
- proportion of core biopsy specimens from invasive recurrent or metastatic lesions; time frame: 6 months after end of recruitment; To determine the proportion of core biopsy specimens obtained from invasive recurrent or metastatic lesions from which adequate amounts of high quality DNA and RNA can be extracted.
- technical failure rate (FR); time frame: 6 months after end of recruitment; To evaluate the technical failure rate (FR) for every single tests (ER, HER2, KI67, PTEN, GEP, CNV and targeted genes screen) using core biopsies.
- ability of the MSPP (IT platform) to sort patients to several simulated protocols; time frame: 6 months after end of recruitment; To evaluate the ability of the MSPP (IT platform) to sort patients to several simulated protocols based on pathological and molecular tests results.
- ease of use of the MSPP; time frame: 6 months after end of recruitment; To evaluate the ease of use of the MSPP (IT platform)

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Countries of Recruitment

  •   Belgium
  •   Germany
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/05/31
  •   30
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Written informed consent for all study procedures according to local regulatory
requirements prior to enrollment into the study.

2. Age ≥ 18 years.

3. Histologically proven metastatic or locally recurrent invasive breast cancer.

4. Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for
research purposes.

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Exclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status >2.

2. The biopsy procedure is estimated to be too risky for the patient.

3. Any bevacizumab treatment administered less than 3 weeks before new biopsy procedure.

4. No appropriate wash-out period for patients on anticoagulation therapy.

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Addresses

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    • Jules Bordet Institute
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    • Breast International Group
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    • Institut Jules Bordet, Brussels, Belgium
    • Sherene Loi, MD, PhD 
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    • Institut Jules Bordet, Brussels, Belgium
    • Sherene Loi, MD, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.