Hypertension in Breast Cancer Patients Receiving Bevacizumab | NCT00674011

Studies
Hypertension in Breast Cancer Patients Receiving Bevacizumab

NCT00674011

Sponsor

Dana-Farber Cancer Institute

Status

Terminated

Last Update Posted

May 6, 2014Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Bevacizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 6, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2014

Last Update Posted Date

May 6, 2014Estimated

Name	Class
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Given as part of standard of care or another research protocol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Erica Mayer, MD MPH	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Institute		Boston	Massachusetts	02215	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D006973	Hypertension

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided