Metastatic Breast CancerBEVAGENENCT01935102
Polymorphism Interaction to Predict Bevacizumab Efficacy
An observational study of Metastatic Breast Cancer, run by University of Pisa at 1 site in Italy.
Trial summary
Although many attempts have been done to identify vascular endothelial growth factor-A (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in advanced cancer patients, the results are still inconclusive. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 169 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Dec 2014
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: metastatic breast cancer patients from eight Italian divisions of Medical Oncology
Who may be able to join
- diagnosis histologically confirmed of metastatic breast cancer
- age (from 18 to 90 years)
- Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1-2)
- hormonal-receptor status (positive or negative)
- previous adjuvant chemotherapy (none, anthracycline or anthracycline plus taxane)
- previous hormonal therapy (adjuvant or metastatic)disease-free interval from the first diagnosis of breast cancer (≤ or >12 months)
Show all 9Show fewer
- extent of disease (≤ or >3 sites)
- location of disease (viscera or bone)
- disease evaluation (measurable or non-measurable)and bevacizumab maintenance (yes or no).
Who cannot join
- Patients with human epidermal growth factor receptor type 2 (HER2)-positive
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical and Experimental Medicine, University of Pisa
Pisa, I Am Not in the U.S. Or Canada, 56125
About this study
Official title: Polymorphism Interaction to Predict Bevacizumab Efficacy in Advanced Breast Cancer Patients: an Exploratory Retrospective Analysis
Although many attempts have been done to identify vascular endothelial growth factor-A (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in advanced cancer patients, the results are still inconclusive.
We will conduct a pharmacogenetic study to assess, in a population of metastatic breast cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2), interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on germline DNA obtained from blood samples and SNPs will be investigated by real-time polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR) methodology will be applied to investigate the interaction between SNPs.
Read the detailed description
Metastatic breast cancer (MBC) patients from eight Italian divisions of Medical Oncology, with histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1, 8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study. MBC patients treated with a first-line chemotherapy including paclitaxel without bevacizumab will be also enrolled as control group.
Sites of metastatic disease will be radiologically re-evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1, in patients with measurable disease. In patients without measurable lesions, progression of disease will be defined when new lesions appeared or when existing lesions evolved. Likewise, in the case of non measurable lesions, deterioration of clinical condition not due to treatment toxicity, will be defined as progression of disease.
Progression-free survival (PFS) will be defined as the period of time from the beginning of the treatment to the first observation of disease progression as above described, or death from any cause. All patients will be assessed for response, PFS and overall survival. Each patient entering the study will sign the informed consent. The protocol has been approved by ethic committee of Azienda Ospedaliera-Universitaria Pisana, Pisa, Italy, (CESM 3077/2010).
Genotyping analyses Blood samples (3 ml) will be collected in ethylenediaminetetraacetic acid (EDTA) tubes and stored at -80°C. Genes and polymorphisms involved in the angiogenesis pathway and already suggested as predictors of bevacizumab response, will be chosen for the present analyses. Germline DNA extraction will be performed using QIAamp DNA Blood Mini Kit (Qiagen, Valencia, California, USA). Allelic discrimination of genes will be performed using an ABI PRISM 7900 SDS instrument (Applied Biosystems, Carlsbad, California, USA) and with validated TaqMan® SNP genotyping assays (Applied Biosystems). PCR reactions will be carried out according to the manufacturer's protocol. Genotyping will be not performed until an adequate number of events (>80% on study population) will be reported in terms of PFS.
Statistical analysis The first aim of this retrospective analysis will be to evaluate the possible role of these investigated gene polymorphisms to predict the bevacizumab response in terms of PFS. The secondary end-points will be the correlations with overall survival (OS) and response rate. All polymorphisms will be analyzed for deviation from the Hardy-Weinberg Equilibrium (HWE) by means of comparison between observed allelic distributions with those expected from the HWE by on χ2 test. Any correlation between gene polymorphisms and response rate will be analyzed by the two-sided Fisher's Exact Test. The association between each individual polymorphism and the most relevant clinical-pathological characteristics with PFS will be tested using a Cox proportional hazards model. The Multifactor Dimensionality Reduction (MDR) methodology will be applied (using version 2.0 beta 6 of MDR software available on http://sourceforge.net/projects/mdr/) to investigate the role of an interaction between gene polymorphisms in identifying biomarkers of paclitaxel plus bevacizumab response.
The genotype combination with the highest PFS benefit correlated with an OS improvement will be chosen for further analyses. The difference in PFS between favourable genetic profiles and the unfavourable genetic profiles will be assessed with the log-rank test and the Kaplan-Meier method to evaluate survival curves. A Cox proportional hazards model, with the possible genetic profiles and the clinical and pathological patient characteristics individually correlated with the PFS, will be used to calculate the adjusted hazards ratio (HR) and the 95% confidence interval (95% CI). A P value of <0.05 will be accepted as statistically significant. The Kaplan-Meier and Cox proportional hazards analyses will be performed using the SPSS version 17.0 (SPSS, Chicago, IL).
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, bevacizumab, single nucleotide polymorphism, VEGF-A, VEGFR-2, IL-8
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | MBC patients treated with a first-line chemotherapy including paclitaxel without bevacizumab | |
| bevacizumab+chemotherapy | histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1, 8 and 15, every 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
progression-free survival in an unselected population of metastatic breast cancer patients treated with bevacizumab combined with first-line paclitaxel assessed through the multifactor dimensionality reduction methodology
Measured: 24 months
Secondary outcomes (1)
Hormonal-receptor status
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Bocci, University of Pisa
- Investigators
- Guido Bocci, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935102
- Sponsor's protocol ID
- CESM3077/2010
- Other IDs
- AIRC-IG9164
- Acronym
- BEVAGENE
- Status last verified
- Dec 2014
- First submitted
- 26 Aug 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113.
PubMed 18160686Miles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3239-47. doi: 10.1200/JCO.2008.21.6457. Epub 2010 May 24.
PubMed 20498403Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612.
PubMed 18824714Pander J, Wessels JAM, Gelderblom H, van der Straaten T, Punt CJA, Guchelaar HJ. Pharmacogenetic interaction analysis for the efficacy of systemic treatment in metastatic colorectal cancer. Ann Oncol. 2011 May;22(5):1147-1153. doi: 10.1093/annonc/mdq572. Epub 2010 Nov 3.
PubMed 21048041Coltelli L, Orlandi P, Finale C, Musettini G, Masini LC, Scalese M, Soria G, Sartori E, Nodari Y, Arrighi G, Bandini A, Banchi M, Tacchi C, Tang D, Salvadori B, Tanganelli L, Giovannelli S, Pistelli M, Cupini S, Lucchesi M, Cosimi A, Lorenzini G, Biasco E, Caparello C, Acconci G, Fontana E, Bona E, Farnesi A, Pellino A, Marini A, De Maio E, Stasi I, Barbara C, Sammarco E, Rosada J, Allegrini G, Bocci G. Bevacizumab and Paclitaxel in Advanced, Hormone Receptor-Positive Breast Cancer: Multifactor Dimensionality Reduction Methodology to Identify Best Overall Survival. Oncol Res. 2026 Apr 22;34(5):13. doi: 10.32604/or.2026.073799. eCollection 2026.
PubMed 42065063Allegrini G, Coltelli L, Orlandi P, Fontana A, Camerini A, Ferro A, Cazzaniga M, Casadei V, Lucchesi S, Bona E, Di Lieto M, Pazzagli I, Villa F, Amoroso D, Scalese M, Arrighi G, Molinaro S, Fioravanti A, Finale C, Triolo R, Di Desidero T, Donati S, Marcucci L, Goletti O, Del Re M, Salvadori B, Ferrarini I, Danesi R, Falcone A, Bocci G. Pharmacogenetic interaction analysis of VEGFR-2 and IL-8 polymorphisms in advanced breast cancer patients treated with paclitaxel and bevacizumab. Pharmacogenomics. 2014 Dec;15(16):1985-99. doi: 10.2217/pgs.14.140.
PubMed 25521357
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism Interaction to Predict Bevacizumab Efficacy in Advanced Breast Cancer Patients: an Exploratory Retrospective Analysis
- ClinicalTrials.gov ID
- NCT01935102
- Acronym / sponsor ID
- BEVAGENE / CESM3077/2010
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, bevacizumab, single nucleotide polymorphism, VEGF-A, VEGFR-2, IL-8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Sep 2013 (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.
Although many attempts have been done to identify vascular endothelial growth factor-A (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in advanced cancer patients, the results are still inconclusive.
We will conduct a pharmacogenetic study to assess, in a population of metastatic breast cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2), interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on germline DNA obtained from blood samples and SNPs will be investigated by real-time polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR) methodology will be applied to investigate the interaction between SNPs.
Detailed description
Metastatic breast cancer (MBC) patients from eight Italian divisions of Medical Oncology, with histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1, 8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study. MBC patients treated with a first-line chemotherapy including paclitaxel without bevacizumab will be also enrolled as control group.
Sites of metastatic disease will be radiologically re-evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1, in patients with measurable disease. In patients without measurable lesions, progression of disease will be defined when new lesions appeared or when existing lesions evolved. Likewise, in the case of non measurable lesions, deterioration of clinical condition not due to treatment toxicity, will be defined as progression of disease.
Progression-free survival (PFS) will be defined as the period of time from the beginning of the treatment to the first observation of disease progression as above described, or death from any cause. All patients will be assessed for response, PFS and overall survival. Each patient entering the study will sign the informed consent. The protocol has been approved by ethic committee of Azienda Ospedaliera-Universitaria Pisana, Pisa, Italy, (CESM 3077/2010).
Genotyping analyses Blood samples (3 ml) will be collected in ethylenediaminetetraacetic acid (EDTA) tubes and stored at -80°C. Genes and polymorphisms involved in the angiogenesis pathway and already suggested as predictors of bevacizumab response, will be chosen for the present analyses. Germline DNA extraction will be performed using QIAamp DNA Blood Mini Kit (Qiagen, Valencia, California, USA). Allelic discrimination of genes will be performed using an ABI PRISM 7900 SDS instrument (Applied Biosystems, Carlsbad, California, USA) and with validated TaqMan® SNP genotyping assays (Applied Biosystems). PCR reactions will be carried out according to the manufacturer's protocol. Genotyping will be not performed until an adequate number of events (>80% on study population) will be reported in terms of PFS.
Statistical analysis The first aim of this retrospective analysis will be to evaluate the possible role of these investigated gene polymorphisms to predict the bevacizumab response in terms of PFS. The secondary end-points will be the correlations with overall survival (OS) and response rate. All polymorphisms will be analyzed for deviation from the Hardy-Weinberg Equilibrium (HWE) by means of comparison between observed allelic distributions with those expected from the HWE by on χ2 test. Any correlation between gene polymorphisms and response rate will be analyzed by the two-sided Fisher's Exact Test. The association between each individual polymorphism and the most relevant clinical-pathological characteristics with PFS will be tested using a Cox proportional hazards model. The Multifactor Dimensionality Reduction (MDR) methodology will be applied (using version 2.0 beta 6 of MDR software available on http://sourceforge.net/projects/mdr/) to investigate the role of an interaction between gene polymorphisms in identifying biomarkers of paclitaxel plus bevacizumab response.
The genotype combination with the highest PFS benefit correlated with an OS improvement will be chosen for further analyses. The difference in PFS between favourable genetic profiles and the unfavourable genetic profiles will be assessed with the log-rank test and the Kaplan-Meier method to evaluate survival curves. A Cox proportional hazards model, with the possible genetic profiles and the clinical and pathological patient characteristics individually correlated with the PFS, will be used to calculate the adjusted hazards ratio (HR) and the 95% confidence interval (95% CI). A P value of <0.05 will be accepted as statistically significant. The Kaplan-Meier and Cox proportional hazards analyses will be performed using the SPSS version 17.0 (SPSS, Chicago, IL).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | –MBC patients treated with a first-line chemotherapy including paclitaxel without bevacizumab |
| bevacizumab+chemotherapy | – | –histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1, 8 and 15, every 4 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast cancer patients from eight Italian divisions of Medical Oncology
Key inclusion criteria (9 listed)
- diagnosis histologically confirmed of metastatic breast cancer
- age (from 18 to 90 years)
- Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1-2)
- hormonal-receptor status (positive or negative)
- previous adjuvant chemotherapy (none, anthracycline or anthracycline plus taxane)
Key exclusion criteria (1 listed)
- Patients with human epidermal growth factor receptor type 2 (HER2)-positive
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
progression-free survival
Time frame: 24 months
progression-free survival in an unselected population of metastatic breast cancer patients treated with bevacizumab combined with first-line paclitaxel assessed through the multifactor dimensionality reduction methodology
1 secondary outcome
Hormonal-receptor status
Time frame: 24 months
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 2 Dec 2014.
- Background: PubMed 18160686Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113.
- Background: PubMed 20498403Miles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3239-47. doi: 10.1200/JCO.2008.21.6457. Epub 2010 May 24.
- Background: PubMed 18824714Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612.
- Background: PubMed 21048041Pander J, Wessels JAM, Gelderblom H, van der Straaten T, Punt CJA, Guchelaar HJ. Pharmacogenetic interaction analysis for the efficacy of systemic treatment in metastatic colorectal cancer. Ann Oncol. 2011 May;22(5):1147-1153. doi: 10.1093/annonc/mdq572. Epub 2010 Nov 3.
- Derived from this study: PubMed 42065063Coltelli L, Orlandi P, Finale C, Musettini G, Masini LC, Scalese M, Soria G, Sartori E, Nodari Y, Arrighi G, Bandini A, Banchi M, Tacchi C, Tang D, Salvadori B, Tanganelli L, Giovannelli S, Pistelli M, Cupini S, Lucchesi M, Cosimi A, Lorenzini G, Biasco E, Caparello C, Acconci G, Fontana E, Bona E, Farnesi A, Pellino A, Marini A, De Maio E, Stasi I, Barbara C, Sammarco E, Rosada J, Allegrini G, Bocci G. Bevacizumab and Paclitaxel in Advanced, Hormone Receptor-Positive Breast Cancer: Multifactor Dimensionality Reduction Methodology to Identify Best Overall Survival. Oncol Res. 2026 Apr 22;34(5):13. doi: 10.32604/or.2026.073799. eCollection 2026.
- Derived from this study: PubMed 25521357Allegrini G, Coltelli L, Orlandi P, Fontana A, Camerini A, Ferro A, Cazzaniga M, Casadei V, Lucchesi S, Bona E, Di Lieto M, Pazzagli I, Villa F, Amoroso D, Scalese M, Arrighi G, Molinaro S, Fioravanti A, Finale C, Triolo R, Di Desidero T, Donati S, Marcucci L, Goletti O, Del Re M, Salvadori B, Ferrarini I, Danesi R, Falcone A, Bocci G. Pharmacogenetic interaction analysis of VEGFR-2 and IL-8 polymorphisms in advanced breast cancer patients treated with paclitaxel and bevacizumab. Pharmacogenomics. 2014 Dec;15(16):1985-99. doi: 10.2217/pgs.14.140.
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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.
Guido Bocci, MD, PhD principal investigator
University of Pisa
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 Metastatic Breast Cancer, run by University of Pisa at 1 site in Italy.
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 9 inclusion and 1 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 2 Dec 2014. 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 Italy. 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?
progression-free survival (time frame: 24 months). 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 NCT01935102, which also lists 6 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 2 Dec 2014.