Clinical trial NCT00674011: Hypertension in Breast Cancer Patients Receiving Bevacizumab
Official title: A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: hypertension
bevacizumab
metastatic breast cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2008-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically or cytologically confirmed breast cancer who will be starting treatment with bevacizumab and chemotherapy.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function
timeFrame: 1 year
measure: To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Erica Mayer, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: