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A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Erica Mayer, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • hypertension
  • bevacizumab
  • metastatic breast cancer
  • Breast Neoplasms
  • Hypertension



Dana-Farber Cancer Institute Boston, Massachusetts  02115