High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents (SAFIR-01)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Breast Cancer |
Other: Biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents |
- number of patients included in early phase trials evaluating targeted drugs [ Time Frame: one year after obtaining the molecular profile ] [ Designated as safety issue: No ]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
- overall survival [ Time Frame: 3 years after inclusion in SAFIR ] [ Designated as safety issue: No ]To evaluate the efficacy of such patient selection in terms of survival
- Progression free survival [ Time Frame: 3 years after inclusion in SAFIR ] [ Designated as safety issue: No ]To evaluate the efficacy of such patient selection in terms of progression free survival
- To evaluate the efficacy of such patient selection in terms of survival response rate [ Time Frame: 3 years after inclusion in SAFIR ] [ Designated as safety issue: No ]To evaluate the efficacy of such patient selection in terms of best response rate
Biospecimen Retention: Samples With DNA
Metastasis biopsy and DNA from biopsy
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
-
Other: Biopsy
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
women or men with metastatic breast cancer
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
Contacts and Locations| Contact: Fabrice André, MD PhD | fabrice.andre@igr.fr | |
| Contact: Marta Jimenez | m-jimenez@unicancer.fr |
| France | |
| Institut Bergonié | Recruiting |
| Bordeaux, France | |
| Contact: Hervé Bonnefoi | |
| Principal Investigator: Hervé Bonnefoi, MD | |
| Centre François Baclesse | Recruiting |
| Caen, France | |
| Contact: Christelle Levy | |
| Principal Investigator: Christelle Levy, MD | |
| Centre Georges François Leclerc | Recruiting |
| Dijon, France | |
| Contact: Séverine Guiu | |
| Principal Investigator: Séverine Guiu, MD | |
| Centre Oscar Lambret | Recruiting |
| Lille, France | |
| Contact: Jacques Bonneterre | |
| Principal Investigator: Jacques Bonneterre, MD | |
| Centre Léon Bérard | Recruiting |
| Lyon, France | |
| Contact: Thomas Bachelot | |
| Principal Investigator: Thomas Bachelot, MD | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, France | |
| Contact: Anthony Gonçalves | |
| Principal Investigator: Anthony Gonçalves, MD | |
| Centre Val D'Aurelle | Recruiting |
| Montpellier, France | |
| Contact: Gilles Romieu | |
| Principal Investigator: Gilles Romieu, MD | |
| Centre Alexis Vautrin | Recruiting |
| Nancy, France | |
| Contact: Elisabeth Luporsi | |
| Principal Investigator: Elisabeth Luporsi, MD | |
| Institut de Cancérologie de l'Ouest/ René Gauducheau | Recruiting |
| Nantes, France | |
| Contact: Mario Campone | |
| Principal Investigator: Mario Campone, MD | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France | |
| Contact: Jean-Marc Ferrero | |
| Principal Investigator: Jean-Marc Ferrero, MD | |
| Institut Curie | Recruiting |
| Paris, France | |
| Contact: Véronique Diéras | |
| Principal Investigator: Véronique Diéras, MD | |
| Institut Jean Godinot | Recruiting |
| Reims, France | |
| Contact: Jean-Christophe Eymard | |
| Principal Investigator: Jean-Christophe Eymard, MD | |
| Centre Eugène Marquis | Recruiting |
| Rennes, France | |
| Contact: Pierre Kerbrat | |
| Principal Investigator: Pierre Kerbrat, MD | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France | |
| Contact: Corinne Veyret | |
| Principal Investigator: Corinne Veyret, MD | |
| Institut Curie/ René Huguenin | Recruiting |
| Saint-Cloud, France | |
| Contact: Etienne Brain | |
| Principal Investigator: Etienne Brain, MD | |
| Centre Paul Strauss | Recruiting |
| Strasbourg, France | |
| Contact: Thierry Petit | |
| Principal Investigator: Thierry Petit, MD | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France | |
| Contact: Florence Dalenc, MD | |
| Principal Investigator: Florence Dalenc, MD | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France | |
| Contact: Fabrice André | |
| Principal Investigator: Fabrice André | |
| Principal Investigator: | Fabrice André, MD phD | Institut Gustave Roussy, Villejuif, France |
More Information
Publications:
| Responsible Party: | Fabrice André / MD PhD, Institut Gustave Roussy |
| ClinicalTrials.gov Identifier: | NCT01414933 History of Changes |
| Other Study ID Numbers: | GRT01/0710 SAFIR-01 |
| Study First Received: | June 17, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013