Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01733628
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2012-11-20
Brief Title:
Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRECOL
Brief Summary:
This 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 PFS Main endpoint
The duration of the study will be approximately 42 months
The duration of the study will be approximately 42 months
Detailed Description:
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 Vascular Endothelial Growth Factor 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 40 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 standard BP Blood Pressure and Holter recording footage with the PFS Moreover will be determined in serum plasma and tumor tissue and certain biomarkers to correlate with efficacy to 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 40 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 standard BP Blood Pressure and Holter recording footage with the PFS Moreover will be determined in serum plasma and tumor tissue and certain biomarkers to correlate with efficacy to treatment with bevacizumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GEI-BEV-2011-02 | OTHER | AEMPS | None |