Hypertension in Breast Cancer Patients Receiving Bevacizumab
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | January 2008 |
| Contact: | Erica Mayer, MD MPH |
| Phone: | 617-632-2335 |
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.
- 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.
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
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