Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Harold J. Burstein, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Faulkner Hospital||Jamaica Plain, Massachusetts 02130|
|Lowell General Hospital||Lowell, Massachusetts 01854|
|New Hampshire Oncology-Hematology PA||Hooksett, New Hampshire 03106|