Metastatic Breast CancerSAFIR-01NCT01414933
High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents
An observational study of Metastatic Breast Cancer, run by UNICANCER at 18 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Biopsy
- How many people
- 423 participants
- Where
- 18 sitesFrance
- Study dates
- May 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: women or men with metastatic breast cancer
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Institut Bergonié
Bordeaux
Centre François Baclesse
Caen
Centre Georges François Leclerc
Dijon
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
Centre Val D'Aurelle
Montpellier
Centre Alexis Vautrin
Nancy
Institut de Cancérologie de l'Ouest/ René Gauducheau
Nantes
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Institut Jean Godinot
Reims
Centre Eugène Marquis
Rennes
Centre Henri Becquerel
Rouen
Institut Curie/ René Huguenin
Saint-Cloud
Centre Paul Strauss
Strasbourg
Institut Claudius Regaud
Toulouse
Institut Gustave Roussy
Villejuif
About this study
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.
Read more
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Breast metastases biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year after obtaining the molecular profile
Secondary outcomes (3)
overall survival
To evaluate the efficacy of such patient selection in terms of survival
Measured: 3 years after inclusion in SAFIR
Progression free survival
To evaluate the efficacy of such patient selection in terms of progression free survival
Measured: 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
Measured: 3 years after inclusion in SAFIR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Fabrice André, MD phD, Principal investigator, Institut Gustave Roussy, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414933
- Sponsor's protocol ID
- GRT01/0710 SAFIR-01
- Acronym
- SAFIR-01
- Status last verified
- May 2017
- First submitted
- 17 Jun 2011
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. No abstract available.
PubMed 21343554Andre F, Bachelot T, Commo F, Campone M, Arnedos M, Dieras V, Lacroix-Triki M, Lacroix L, Cohen P, Gentien D, Adelaide J, Dalenc F, Goncalves A, Levy C, Ferrero JM, Bonneterre J, Lefeuvre C, Jimenez M, Filleron T, Bonnefoi H. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicentre, prospective trial (SAFIR01/UNICANCER). Lancet Oncol. 2014 Mar;15(3):267-74. doi: 10.1016/S1470-2045(13)70611-9. Epub 2014 Feb 7.
PubMed 24508104
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents
- ClinicalTrials.gov ID
- NCT01414933
- Acronym / sponsor ID
- SAFIR-01 / GRT01/0710 SAFIR-01
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women or men with metastatic breast cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Age <18
- Life expectancy <3 months
- Symptomatic or progressing brain metastases
- Progressive patients at the time of biopsy
- LVEF <50% (MUGA or ultrasonography)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyBreast metastases biopsy | Other | – |
Primary outcome
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
3 secondary outcomes
overall survival
Time frame: 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 survival response rate
Time frame: 3 years after inclusion in SAFIR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 21343554Andre 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. No abstract available.
- Derived from this study: PubMed 24508104Andre F, Bachelot T, Commo F, Campone M, Arnedos M, Dieras V, Lacroix-Triki M, Lacroix L, Cohen P, Gentien D, Adelaide J, Dalenc F, Goncalves A, Levy C, Ferrero JM, Bonneterre J, Lefeuvre C, Jimenez M, Filleron T, Bonnefoi H. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicentre, prospective trial (SAFIR01/UNICANCER). Lancet Oncol. 2014 Mar;15(3):267-74. doi: 10.1016/S1470-2045(13)70611-9. Epub 2014 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice André, MD phD principal investigator
Institut Gustave Roussy, Villejuif, France
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by UNICANCER at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients included in early phase trials evaluating targeted drugs (time frame: one year after obtaining the molecular profile). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414933, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.