Hypertension in Breast Cancer Patients Receiving Bevacizumab - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00674011

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: Bevacizumab

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer High Blood Pressure

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Given as part of standard of care or another research protocol

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed metastatic breast cancer who will be starting treatment with bevacizumab and chemotherapy.

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed metastatic (Stage 4) 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. Treatment may only include bevacizumab with paclitaxel or bevacizumab with vinorelbine.
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.
Amenorrheic, defined as absence of menses for 6 months or more

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
Enrolled on DFCI clinical trial 06-402 (ZD6474 and metronomic chemotherapy) as cardiovascular testing is already incorporated in that protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674011

Contacts

Contact: Erica Mayer, MD MPH	617-632-2335
Contact: Jason Russak	617-632-4915

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Erica Mayer, MD MPH

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Erica Mayer, MD MPH )
Study ID Numbers:	07-149
Study First Received:	May 6, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00674011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

hypertension
bevacizumab
metastatic breast cancer

Study placed in the following topic categories:

Skin Diseases
Vascular Diseases
Breast Neoplasms

Bevacizumab
Breast Diseases
Hypertension

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009