An observational study in Metastatic Breast Cancer, sponsored by UNICANCER. Completed at 18 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by UNICANCER · Observational
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 423 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →UNICANCER is the lead sponsor of 219 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
women or men with metastatic breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Breast metastases biopsy
number of patients included in early phase trials evaluating targeted drugs
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
Time frame: one year after obtaining the molecular profile
overall survival
To evaluate the efficacy of such patient selection in terms of survival
Time frame: 3 years after inclusion in SAFIR
Progression free survival
To evaluate the efficacy of such patient selection in terms of progression free survival
Time frame: 3 years after inclusion in SAFIR
To evaluate the efficacy of such patient selection in terms of survival response rate
To evaluate the efficacy of such patient selection in terms of best response rate
Time frame: 3 years after inclusion in SAFIR
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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