Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Breast Cancer
- Sponsor
- Harold J. Burstein, MD, PhD
- Enrollment
- 29
- Locations
- 7
- Primary Endpoint
- Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Detailed Description
* Participants will receive bevacizumab intravenously every 2 weeks. They will also receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments will alternate between receiving all three drugs (1st week, third week, fifth week, etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth week, etc.) A treatment cycle lasts four weeks. * During all treatment cycles a physical exam will be performed and the participant will be asked general health and specific questions about any problems they are experiencing. * X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in order to assess the effect of the study treatment on the participants cancer. These tests are considered standard of care in patients receiving chemotherapy. * Once a week blood counts will be performed and at least every 4 weeks, chemistry and other tests to measure any additional effect of the study drug and disease status will be checked. These tests are also considered standard of care for patients receiving chemotherapy. * At the beginning of the study and at the 4- and 8-week time point, additional blood will be drawn in order to conduct research blood tests to measure the presence of cancer cells in the blood. * A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the participant in on the study. * Participants can remain on the research study as long as the study treatment appears to be working and they are not experiencing unacceptable side effects.
Investigators
Harold J. Burstein, MD, PhD
Associate Professor of Medicine
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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
- •18 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
Exclusion Criteria
- •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
Arms & Interventions
First line treatment
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
Intervention: bevacizumab
First line treatment
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
Intervention: vinorelbine
First line treatment
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
Intervention: trastuzumab
Second line treatment
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.
Intervention: bevacizumab
Second line treatment
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.
Intervention: vinorelbine
Second line treatment
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.
Intervention: trastuzumab
Outcomes
Primary Outcomes
Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.
Time Frame: 1 year
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.
Secondary Outcomes
- Objective Response Rate(1 year)
- Progression-free Survival(3 years)