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Trial record 1 of 1 for:    BRECOL
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Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer (BRECOL)

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ClinicalTrials.gov Identifier: NCT01733628
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.


Condition or disease
Metastatic Colorectal Cancer Metastatic Breast Cancer

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 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 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.

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Study Type : Observational
Actual Enrollment : 143 participants
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).
Actual Study Start Date : October 23, 2012
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort
Bevacizumab + Chemotherapy
Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.



Primary Outcome Measures :
  1. Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    The incidence of hypertension was studied during treatment with bevacizumab combined with chemotherapy. A Cox regression analysis was performed, entering as a dependent variable the PFS and as independent variable the Arterial Hypertension (AHT) (yes/no). AHT is introduced in the model of Cox as a time-dependent variable since its situation can change as length of the study. The date on which the AHT changes (passes from normotensive to hypertensive).

  2. Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    The PFS is the time from the patient receiving the first dose of chemotherapy for advanced disease to the date of progression, the administration of a new antineoplastic treatment that does not contain bevacizumab or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Number of Participants With "White Coat" AHT While at Home [ Time Frame: Cycle 1, cycle 2, and cycle 3, up to 9 weeks ]

    The incidence of "white coat" arterial hypertension (AHT) was evaluated comparing each of the measurements in medical attention (in a doctor office) with the measurement that was made at home (without a doctor).

    White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings.


  2. Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure [ Time Frame: Baseline, cycle 1, cycle 2, and cycle 3, up to 9 weeks ]

    The incidence of "white coat" arterial hypertension (AHT) was evaluated comparing each of the measurements with the measurement that was made in the hospital. Ambulatory Blood Pressure Monitoring (ABPM) is when the blood pressure is being measured as patient moves around, living her normal daily life.

    White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings.



Biospecimen Retention:   Samples With DNA
Blood samples (serum or plasma) Tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic (disseminated at the time of diagnosis) breast cancer or colorectal cancer, treated with bevacizumab.
Criteria

Inclusion Criteria:

May only participate in the study patients (women and men) who meet all the following criteria:

  1. MCC or MBC patients with chemotherapy and bevacizumab established indication. The first line systemic treatment planned for patients with MCC should be based in combination chemotherapy (oxaliplatin / irinotecan plus fluoropyrimidine) associated with bevacizumab. The first line systemic treatment planned for MBC patients should be based on a combination of paclitaxel or capecitabine plus bevacizumab.
  2. Presence of measurable or evaluable disease according to RECIST 1.1, for the evaluation of the response to treatment.
  3. Equal or more than 18 years old.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Signed written informed consent.
  6. Women of childbearing potential must have a negative pregnancy test in serum or urine conducted in the 7 days prior to the administration of chemotherapeutic treatment assigned by your doctor, and accept the use of double barrier contraception during the study (Note : Patients who are not of childbearing age may participate without using contraceptives. Women who are of childbearing age are those who: 1) have reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) within postmenopausal interval as determined by the laboratory, or 12 months of spontaneous amenorrhea), 2) have undergone bilateral oophorectomy with or without hysterectomy 6 weeks before, or 3) have undergone bilateral tubal ligation). Men also should use an adequate contraception method.

Exclusion Criteria:

Patients meeting any of the following circumstances will be excluded from the study:

  1. Have received prior systemic anticancer therapy with chemotherapy for advanced disease or prior treatment with bevacizumab.
  2. Treatment with an investigational agent or biological agent within 30 days prior to inclusion in the study.
  3. Contraindications to treatment with chemotherapy and bevacizumab according to summary products characteristics.
  4. Background or current history (within five years before the start of treatment) of other malignancies, except for colorectal carcinoma and breast cancer (patients with basal cell carcinoma or squamous cell skin or cervical carcinoma in situ treated curative may be included in the study).
  5. Life expectancy less than 3 months.
  6. Patients who are pregnant or breastfeeding.
  7. Patients with an inadequate organ function (bone marrow, kidney and liver)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733628


Locations
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Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital General Universitario de Alicante
Alicante, Spain
Complejo Hospitalario Universitario Reina Sofía
Córdoba, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Centro Oncológico MD Anderson
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Roche Farma, S.A
Investigators
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Study Director: Study Director Hospital General Universitario de Elche
  Study Documents (Full-Text)

Documents provided by Spanish Breast Cancer Research Group:
Study Protocol  [PDF] February 23, 2012
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT01733628    
Other Study ID Numbers: GEICAM/2011-04
GEI-BEV-2011-02 ( Other Identifier: AEMPS )
First Posted: November 27, 2012    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: December 2019
Keywords provided by Spanish Breast Cancer Research Group:
Hypertension
Bevacizumab Response Predictors
Metastatic Breast Cancer
Metastatic Colon Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Hypertension
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases