High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents (SAFIR-01)

May 3, 2017 updated by: UNICANCER

High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).

From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen.

Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations.

High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples.

In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Institut Bergonié
      • Caen, France
        • Centre Francois Baclesse
      • Dijon, France
        • Centre Georges François Leclerc
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • Institut Paoli Calmettes
      • Montpellier, France
        • Centre Val d'Aurelle
      • Nancy, France
        • Centre Alexis Vautrin
      • Nantes, France
        • Institut de Cancérologie de l'Ouest/ René Gauducheau
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Institut Curie
      • Reims, France
        • Institut Jean Godinot
      • Rennes, France
        • Centre Eugène Marquis
      • Rouen, France
        • Centre Henri Becquerel
      • Saint-Cloud, France
        • Institut Curie/ René Huguenin
      • Strasbourg, France
        • Centre Paul Strauss
      • Toulouse, France
        • Institut Claudius Regaud
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

women or men with metastatic breast cancer

Description

Inclusion Criteria:

  • Men and Women with histologically diagnosed breast cancer
  • Metastatic relapse or stage IV breast cancer at diagnosis
  • Metastases amenable to biopsy
  • Age <70 years old
  • PS 0/1
  • No restriction regarding the number of previous chemotherapy or endocrine therapies

Exclusion Criteria:

  • Age <18
  • Life expectancy <3 months
  • Symptomatic or progressing brain metastases
  • Progressive patients at the time of biopsy
  • LVEF <50% (MUGA or ultrasonography)
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count < 1.5 x 109/L
  • Platelet count < 100 x 109/L
  • Haemoglobin < 90 g/L
  • ASAT/ALAT > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
  • Total bilirubin > 1.5 times ULN
  • Creatinine >1.5 times ULN
  • Corrected calcium > ULN
  • Phosphate > ULN
  • Abnormal blood coagulation that contra-indicates biopsy
  • Patients deprived of liberty or placed under the authority of a tutor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients included in early phase trials evaluating targeted drugs
Time Frame: one year after obtaining the molecular profile
To use whole genome / integrated biology approach to drive patients in early clinical trials. The goal is to include at least 30% of the patients in a clinical trial evaluating targeted agent, according to the molecular alteration detected on high throughput technologies
one year after obtaining the molecular profile

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years after inclusion in SAFIR
To evaluate the efficacy of such patient selection in terms of survival
3 years after inclusion in SAFIR
Progression free survival
Time Frame: 3 years after inclusion in SAFIR
To evaluate the efficacy of such patient selection in terms of progression free survival
3 years after inclusion in SAFIR
To evaluate the efficacy of such patient selection in terms of survival response rate
Time Frame: 3 years after inclusion in SAFIR
To evaluate the efficacy of such patient selection in terms of best response rate
3 years after inclusion in SAFIR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Collaborators

Ministry of Health, France
Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Fabrice André, MD phD, Institut Gustave Roussy, Villejuif, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRT01/0710 SAFIR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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