Hypertension in Breast Cancer Patients Receiving Bevacizumab

NCT00674011 | Terminated

• 1 other identifier: 07-149
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

hypertension; bevacizumab; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function

  1 year

• To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy.

  1 year

Interventions

Bevacizumab DRUG

Given as part of standard of care or another research protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hypertension

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Erica Mayer, MD MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)