Clinical trial · Observational
A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
A Combined Genome-Wide Association Study (GWAS) and microRNA (miRNA) Profiling Approach for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the low rate of recruitment.
Summary
Brief summary (as posted)
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. 1. -To identify genetic variants as bevacizumab response predictors in metastatic breast cancer 2. 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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Invasive Nos | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Genome-Wide Association Study (GWAS) and microRNA (miRNA) profiling for identification of genetic variants and blood miRNA signatures predictors of bevacizumab response.
- timeFrame
- 18 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available