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

NCT01598285 | Terminated

• 1 other identifier: GEICAM/2011-07
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. Only patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab, will be included.

1. 1.-To identify genetic variants as bevacizumab response predictors in metastatic breast cancer
2. 2.To identify miRNA signatures in whole blood as bevacizumab response predictors in metastatic breast cancer patients.

Conditions

Breast Cancer Invasive Nos

Keywords

Genome-Wide; GWAS; microRNA; miRNA; Bevacizumab Response Predictors; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Hoffmann-La Roche: collaborator
• Roche Farma, S.A: collaborator

Study Sites (1)

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Hospital Clínico Universitario Virgen de la Victoria

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 15, 2012
• Study Start: April 18, 2012
• Primary Completion: April 10, 2013
• Study Completion: April 10, 2013
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

ES (1)