Breast Cancer Invasive NosNCT01598285
A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
An observational study of Breast Cancer Invasive Nos, run by Spanish Breast Cancer Research Group at 1 site in Spain.
Trial summary
GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100 non-responders and 100 best responders) metastatic breast cancer patients, will search for specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive Nos
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 18 Apr 2012to 10 Apr 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab.
Who may be able to join
- patients with breast cancer, at a disseminated stage
- patients treated with bevacizumab in combination with weekly paclitaxel as first line chemotherapy and who have progressed
- alive patients authorizing the extraction and analysis of their biological samples.
Who cannot join
- patients with a second neoplasia
- deceased patients
- patients who have not agreed to participate in the study
- HER2 positive patients
- patients with CNS metastases when first treated with bevacizumab in combination with paclitaxel
- patients with local-regional recurrence only and
- patients with status NED (resected metastases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combined Genome-Wide Association Study (GWAS) and microRNA (miRNA) Profiling Approach for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100 non-responders and 100 best responders) metastatic breast cancer patients, will search for specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response. Only patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab, will be included.
- -To identify genetic variants as bevacizumab response predictors in metastatic breast cancer
- To identify miRNA signatures in whole blood as bevacizumab response predictors in metastatic breast cancer patients.
Read more
The main endpoint will be progression-free survival (PFS)
The duration of the study will be approximately 18 months
Read the detailed description
In certain solid neoplasias, antiangiogenic therapies improve response rates and time to progression. However, treatment with antiangiogenic drugs do not improve patient´s overall survival, in addition to being quite toxic and expensive. It is therefore critical to identify reliable predictive factors for drug efficacy and potential toxicity. Pharmacogenomics and pharmacogenetics are emerging as important tools in the optimization of different therapeutic strategies against cancer. Thus, gene expression profiling and genome-wide association studies (GWAS) offer the promise to more effectively tailor individual cancer treatments by identifying new biomarkers for clinical efficacy. They likely represent a real progress in our understanding of cancer as a complex process and an improvement in patient management and treatment. This grant proposal is aimed at: i) identify genetic variants (SNPs) responsible for the different bevacizumab treatment response observed in metastatic breast cancer patients and ii) determine specific blood microRNA (miRNA) signatures associated with the bevacizumab response The reference endpoint for patient selection will be progression free survival (PFS). To increase the statistical significance of the study, patients will be categorized in two groups: non-responders (PFS<12 weeks) and best responders (PFS>52 weeks). Blood samples will be drawn prospectively from selected patients, they will be processed to obtain purified total DNA and RNA and, finally, they will be analyzed by next-gen GWAS and miRNA profiling, respectively. DNA samples will be hybridized to ultrahigh density Omni microarrays, containing 2.5 million genetic variants while RNA samples will be hybridized to Affymetrix microarrays containing an up-to-date collection of human miRNA sequences (miRBase v15, 1105 human miRNA probes). Standard computational analysis of both sets of microarray data will performed and the results will be correlated with the main endpoint of the study (PFS).
- Conditions
- Breast Cancer Invasive Nos
- Keywords
- Genome-Wide, GWAS, microRNA, miRNA, Bevacizumab Response Predictors, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome-Wide Association Study (GWAS) and microRNA (miRNA) profiling for identification of genetic variants and blood miRNA signatures predictors of bevacizumab response.
Genome-Wide Association Study (GWAS) and microRNA profiling will be performed from DNA and microRNA obtained from blood samples of metastatic breast cancer patients treated with Bevacizumab. Next-generation microarray thecnologies will be performed. Patients will be categorized in two groups: non-responders and best responders. Results of standard computational analysis of microarrays will be correlated with progression free survival data for identification of genetic variants and microRNA signatures predictors of Bevacizumab response
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study start18 Apr 2012
- Primary completion10 Apr 2013
- Study completion10 Apr 2013
Why it stopped: Due to the low rate of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Invasive NosStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Roche Farma, S.A
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital Clínico Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598285
- Sponsor's protocol ID
- GEICAM/2011-07
- Other IDs
- GEICAM/2011-07
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2012
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Genome-Wide Association Study (GWAS) and microRNA (miRNA) Profiling Approach for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01598285
- Acronym / sponsor ID
- GEICAM/2011-07
- Conditions
- Breast Cancer Invasive Nos
- Keywords
- Genome-Wide, GWAS, microRNA, miRNA, Bevacizumab Response Predictors, Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the low rate of recruitment.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Roche Farma, S.A
- Study start
- 18 Apr 2012 (actual)
- Primary completion
- 10 Apr 2013 (actual)
- Study completion
- 10 Apr 2013 (actual)
- First posted
- 15 May 2012 (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.
GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100 non-responders and 100 best responders) metastatic breast cancer patients, will search for specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response. Only patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab, will be included.
- -To identify genetic variants as bevacizumab response predictors in metastatic breast cancer
- To identify miRNA signatures in whole blood as bevacizumab response predictors in metastatic breast cancer patients.
The main endpoint will be progression-free survival (PFS)
The duration of the study will be approximately 18 months
Detailed description
In certain solid neoplasias, antiangiogenic therapies improve response rates and time to progression. However, treatment with antiangiogenic drugs do not improve patient´s overall survival, in addition to being quite toxic and expensive. It is therefore critical to identify reliable predictive factors for drug efficacy and potential toxicity. Pharmacogenomics and pharmacogenetics are emerging as important tools in the optimization of different therapeutic strategies against cancer. Thus, gene expression profiling and genome-wide association studies (GWAS) offer the promise to more effectively tailor individual cancer treatments by identifying new biomarkers for clinical efficacy. They likely represent a real progress in our understanding of cancer as a complex process and an improvement in patient management and treatment. This grant proposal is aimed at: i) identify genetic variants (SNPs) responsible for the different bevacizumab treatment response observed in metastatic breast cancer patients and ii) determine specific blood microRNA (miRNA) signatures associated with the bevacizumab response The reference endpoint for patient selection will be progression free survival (PFS). To increase the statistical significance of the study, patients will be categorized in two groups: non-responders (PFS<12 weeks) and best responders (PFS>52 weeks). Blood samples will be drawn prospectively from selected patients, they will be processed to obtain purified total DNA and RNA and, finally, they will be analyzed by next-gen GWAS and miRNA profiling, respectively. DNA samples will be hybridized to ultrahigh density Omni microarrays, containing 2.5 million genetic variants while RNA samples will be hybridized to Affymetrix microarrays containing an up-to-date collection of human miRNA sequences (miRBase v15, 1105 human miRNA probes). Standard computational analysis of both sets of microarray data will performed and the results will be correlated with the main endpoint of the study (PFS).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab.
Key inclusion criteria (3 listed)
- patients with breast cancer, at a disseminated stage
- patients treated with bevacizumab in combination with weekly paclitaxel as first line chemotherapy and who have progressed
- alive patients authorizing the extraction and analysis of their biological samples.
Key exclusion criteria (7 listed)
- patients with a second neoplasia
- deceased patients
- patients who have not agreed to participate in the study
- HER2 positive patients
- patients with CNS metastases when first treated with bevacizumab in combination with paclitaxel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genome-Wide Association Study (GWAS) and microRNA (miRNA) profiling for identification of genetic variants and blood miRNA signatures predictors of bevacizumab response.
Time frame: 18 months
Genome-Wide Association Study (GWAS) and microRNA profiling will be performed from DNA and microRNA obtained from blood samples of metastatic breast cancer patients treated with Bevacizumab. Next-generation microarray thecnologies will be performed. Patients will be categorized in two groups: non-responders and best responders. Results of standard computational analysis of microarrays will be correlated with progression free survival data for identification of genetic variants and microRNA signatures predictors of Bevacizumab response
Results and safety
The study was stopped early (reason given: Due to the low rate of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
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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.
Study Director study director
Hospital Clínico Universitario Virgen de la Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Invasive Nos, run by Spanish Breast Cancer Research Group at 1 site in Spain.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was stopped early (reason given: Due to the low rate of recruitment.). Results are not available in the source record.
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?
Genome-Wide Association Study (GWAS) and microRNA (miRNA) profiling for identification of genetic variants and blood miRNA signatures predictors of bevacizumab response. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.