Hypertension in Breast Cancer Patients Receiving Bevacizumab

May 5, 2014 updated by: Erica Mayer, MD, MPH, Dana-Farber Cancer Institute

A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

This research study will look at the effect of an anti-angiogenesis medication called Bevacizumab on blood vessels. Anti-angiogenesis medicines fight cancer by cutting off a tumor's blood supply, starving the tumor of nutrients and oxygen. Previous studies have shown these types of drugs can cause hypertension. The purpose of this study is to help researchers better understand why these drugs cause hypertension. This information will assist researchers in learning how to control this side effect.

Study Overview

Status

Terminated

Conditions

Breast Cancer

Intervention / Treatment

Drug: Bevacizumab

Detailed Description

Participants will begin this research study within 14 days of starting Bevacizumab, either as part of standard treatment or as part of another clinical trial.
Participants will have an ultrasound test done at baseline, and after completion of their first and second cycles of therapy.
Vital signs and blood tests will be performed a the start of the study, and after completion of the first and second cycles of therapy.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed breast cancer who will be starting treatment with bevacizumab and chemotherapy.

Description

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer
Must be starting combination treatment with bevacizumab and chemotherapy. Treatment may not have already started. Patients may receive therapy either on or off of a clinical trial.
Any number of prior chemotherapy or biological therapy regimens is acceptable.
Either no history of hypertension, defined as Blood Pressure <140/90mm Hg on no antihypertensive therapy, or medically controlled pre-existing hypertension, defined as Blood Pressure < 140/90mm HG on one non-angiotensin converting enzyme inhibitor (ACE-I) or non-angiotensin receptor blocking (ARB) medication.

Exclusion Criteria:

History of uncontrolled hypertension within the previous 6 months
Inability to assess blood pressure or have prolonged blood pressure cuff inflation due to history of bilateral lymph node dissections, presence of an indwelling venous access device, or other condition
Concurrent use of a statin medication
Systolic blood pressure < 100mm Hg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate changes in flow-mediated vasodilation (FMD) from baseline to treatment timepoints in an effort to explore the relationships between exposure to bevacizumab, eNOS activity, and vascular dysfunction. Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function Time Frame: 1 year	1 year
To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy. Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: Erica Mayer, MD MPH, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)