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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01414933
Other study ID # GRT01/0710 SAFIR-01
Secondary ID
Status Completed
Phase N/A
First received June 17, 2011
Last updated May 3, 2017
Start date May 2011
Est. completion date May 2013

Study information

Verified date May 2017
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 423
Est. completion date May 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Biopsy
Breast metastases biopsy

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
UNICANCER Gustave Roussy, Cancer Campus, Grand Paris, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Andre F, Delaloge S, Soria JC. Biology-driven phase II trials: what is the optimal model for molecular selection? J Clin Oncol. 2011 Apr 1;29(10):1236-8. doi: 10.1200/JCO.2010.31.6877. Epub 2011 Feb 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year after obtaining the molecular profile
Secondary overall survival To evaluate the efficacy of such patient selection in terms of survival 3 years after inclusion in SAFIR
Secondary Progression free survival To evaluate the efficacy of such patient selection in terms of progression free survival 3 years after inclusion in SAFIR
Secondary 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 3 years after inclusion in SAFIR
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