Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer

NCT00670982 | Completed Phase 2 Results DMC

• 1 other identifier: 07-214
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.

Conditions

Breast Cancer

Keywords

HER2 positive; bevacizumab; vinorelbine; trastuzumab

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.

  Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.

  1 year

Secondary Outcomes (2)

• Objective Response Rate

  1 year

• Progression-free Survival

  3 years

Study Arms (2)

First line treatment

EXPERIMENTAL

Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week

Drug: bevacizumab; Drug: vinorelbine; Drug: trastuzumab

Second line treatment

EXPERIMENTAL

Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.

Drug: bevacizumab; Drug: vinorelbine; Drug: trastuzumab

Interventions

bevacizumab DRUG

Given intravenously every 2 weeks

Also known as: Avastin

First line treatment; Second line treatment

vinorelbine DRUG

Given intravenously once a week

Also known as: Navelbine

First line treatment; Second line treatment

trastuzumab DRUG

Given intravenously once a week

Also known as: Herceptin

First line treatment; Second line treatment

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed invasive breast cancer, with metastatic disease.
• HER2-positive tumor
• Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan
• years of age or older
• Life expectancy of more than 12 weeks
• ECOG Performance Status of 0 or 1
• Normal organ and marrow function as outlined in the protocol
• Left ventricular ejection fraction 50% or greater as determined by RVG or echocardiogram within 30 days prior to initiation of protocol therapy
• Patients with stable or previously treated CNS metastases are eligible for study participation, provided there is no history of clinically significant CNS bleeding
• Men and women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
• COHORT A:
• No prior chemotherapy for treatment of metastatic breast cancer
• May NOT have received prior treatment with trastuzumab for recurrent or metastatic breast cancer
• No prior vinorelbine for treatment of breast cancer
• No prior bevacizumab for treatment of breast cancer

You may not qualify if:

• Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier
• Concurrent radiation therapy
• History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study
• Prior therapy with bevacizumab or vinorelbine
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Inadequately controlled hypertension
• Prior history of hypertensive crisis of hypertensive encephalopathy
• NHYA Grade II or greater congestive heart failure
• History of myocardial infarction of unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Progressive or untreated CNS metastases
• Significant vascular disease within 6 months prior to study enrollment
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

Sponsors & Collaborators

• Harold J. Burstein, MD, PhD: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator
• Genentech, Inc.: collaborator
• New Hampshire Oncology-Hematology PA: collaborator
• Lowell General Hospital: collaborator
• Hartford Hospital: collaborator

Study Sites (7)

Hartford Hospital

Hartford, Connecticut, 06101, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01850, United States

Location

New Hampshire Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Vinorelbine; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Harold J. Burstein, MD
• Organization: Dana-Farber Cancer Institute

hal_burstein@dfci.harvard.edu

617-632-2335

Study Officials

• Harold J. Burstein, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 13, 2013
• Results First Posted: May 13, 2013

Record last verified: 2013-03

Locations

US (7)