A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer
- All patients will receive trastuzumab then be randomized into one of two arms. Arm A:
Trastuzumab in combination with weekly vinorelbine and Arm B: Trastuzumab in
combination with a weekly taxane-based regimen, either paclitaxel or docetaxel, chosen
at the discretion of the investigator.
- Treatment is administered on an outpatient basis. Trastuzumab is administered weekly.
There is a one-time loading dose for the first week of the first cycle. For that
initial treatment, only, the trastuzumab dose is 4mg/kg. The dose for all subsequent
weekly trastuzumab treatments is 2mg/kg.
- Arm A: vinorelbine is administered every week and the dose is adjusted based on the
absolute neutrophil count for that week. Vinorelbine is given after trastuzumab.
- Arm B: Either paclitaxel given weekly (dose bases on absolute neutrophil count) or
docetaxel given on weeks 1,2,3,5,6,7 of each 8-week cycle (dose based upon absolute
neutrophil count). Patients on paclitaxel will also receive dexamethasone,
diphenhydramine and ranitidine to help prevent allergic or hypersensitivity reactions.
Patients on docetaxel will receive dexamethasone to help reduce fluid retention or
- Every 8 weeks the patients cancer will be re-evaluated to see if the treatment is
working. If the treatment appears to be working, treatment will continue. Standard
radiological testing (x-rays, CT scan, radioactive drug scans, or MRI's) will be used
to follow the disease treatment.
- Heart function will be measured after 16 weeks to be sure it is safe to continue
- Every 8 weeks, patients' will be asked to complete a brief written survey that asks
about symptoms and side effects.
- Patients' will remain on the treatment as long as there is no disease progression or
unacceptable side effects.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.
Harold Burstein, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|