Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Metastatic Colorectal Cancer (BRECOL)
Recruitment status was: Recruiting
GEI-BEV-2011-02 is a multicenter, post-authorization observational with prospective follow-up (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic colorectal cancer. The hypertension will be evaluated as a predictor of efficacy of bevacizumab associated with chemotherapy, in terms of progression-free survival (Main endpoint).
The duration of the study will be approximately 42 months.
Metastatic Colorectal Cancer
Metastatic Breast Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation Study of Hypertension as a Predictor of Efficacy Bevacizumab (BV) in Combination With Chemotherapy (CT) in Metastatic Colorectal Cancer (MCC) and Metastatic Breast Cancer (MBC).|
- Blood Pressure [ Time Frame: 3 months after the first blood pressure assessment ] [ Designated as safety issue: No ]
Blood Pressure will be determined at a baseline, within 14 days before the start of treatment, and on the first day of cycles 1, 2 and 3.
Measurement tools for recording blood pressure:
- Holter o Ambulatory Blood Pressure Monitoring
- Standard Register Blood Pressure following the guidelines of the European Society of Cardiology and Hypertension, 2007
- Biomarkers in serum, plasma and tumoral tissue [ Time Frame: 12 months after last patient included finishes the study ] [ Designated as safety issue: No ]
Evaluate in serum or plasma biomarkers associated with hypertension and angiogenesis [such as placental growth factor (PIGF), the growth factor vascular endothelial dependent (VEGF), the fraction soluble receptor factor vascular endothelial growth (sVEGFR1), interleukin 6 (IL-6) and von Willebrand factor (recognized marker of damage / endothelial dysfunction), among others], and its association with the efficacy to treatment with bevacizumab.
- Evaluate in tumor tissue biomarkers related to hypertension and angiogenesis (such as genetic variants and differences in the expression levels of VEGF, ARBs, AGTR, among others), and its association with efficacy to treatment with bevacizumab.
- Evaluate in genomic DNA genetic variants (in genes such as VEGF, VEGFR1, AGTR, AGT, ACE, ADRB1, ADRB2, ADRB3, GNAS, GNB3, etc.) involved in the development of hypertension secondary to treatment with bevacizumab.
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Hypertension (HT) is the most common side effect seen in trials of bevacizumab in combination with chemotherapy. Based on the hypothesis that the development of hypertension during treatment would be an indicative of the successful blockade of the VEGF pathway, different studies have explored retrospectively the relationship between hypertension and the results of treatment with bevacizumab.
This study aims to demonstrate the association between hypertension (diagnosed optimally) with efficacy to treatment with bevacizumab prospectively and secondly verify if blood pressure measures taken at home are a reflection of a diagnosis of hypertension.
Also have been explored different molecular markers involved in the pathway of VEGF which might be used as predictors of response. Therefore, this study includes the collection of blood samples (serum or plasma) and tumor tissue of patients included in this study, with the aim of exploring biomarkers that correlate with treatment efficacy and toxicity.
The diagnosis of hypertension (HT) will be performed using a Holter recording, and standard blood pressure footage will be collected during the first three cycles of treatment given the Common Toxicity Criteria of the National Cancer Institute-NCI CTCAE version 4.0 and the guidelines of the European Society of Cardiology and Hypertension, 2007.
Will be collected a sample of primary tumor and blood for patients who previously have consented it. Samples will be sent to a central laboratory for analysis of biomarkers.
An interim analysis will be conducted to assess the true incidence of hypertension. Based on this analysis, will be evaluated the need to recalculate the sample size.
At the end of the study, will be performed an analysis of correlation of data measured by HTA and Holter recording footage with the SLP standard TA. Moreover will be determined in serum, plasma and tumor tissue and certain biomarkers to correlate with efficacy to treatment with bevacizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733628
|Sabadell, Barcelona, Spain, 08208|
|A Coruña, Spain, 15006|
|Hospital Virgen de la Salud|
|Toledo, Spain, 45004|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Study Chair:||Alvaro Rodríguez Lescure||Hospital General Universitario de Elche|