Breast Cancer
Conditions
Keywords
hypertension, bevacizumab, metastatic breast cancer
Brief summary
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
* 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.
Interventions
DRUGBevacizumab
Given as part of standard of care or another research protocol
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | 1 year |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed