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A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer
A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer

NCT01598285

TerminatedN/A

Sponsor: Spanish Breast Cancer Research Group

Conditions: Breast Cancer Invasive Nos

Countries: Spain

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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)
Locations (1)
  • Málaga, Spain