Hypertension in Breast Cancer Patients Receiving Bevacizumab

Breast Cancer Clinical Trial

Official title:

A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00674011
• Other study ID #: 07-149
• Status: Terminated
• Phase: N/A
• First received: May 6, 2008
• Last updated: May 5, 2014
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hypertension

Intervention

Drug:
• Bevacizumab
Given as part of standard of care or another research protocol

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function		1 year	No
Secondary	To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy.		1 year	No