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NCT Number: NCT01414933

High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Other

Breast metastases biopsy

Primary outcomes

  1. 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

Secondary outcomes

  1. overall survival

    Time frame: 3 years after inclusion in SAFIR

    To evaluate the efficacy of such patient selection in terms of survival

  2. 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. 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

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

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

Registry information

Acronym: SAFIR-01

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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