Hypertension in Breast Cancer Patients Receiving Bevacizumab

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|Given as part of standard of care or another research protocol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, bevacizumab, metastatic breast cancer