A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With Her-2 Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy – Phase III

Histologically confirmed breast cancer and clinical evidence of metastatic disease;HER-2+ tumors as determined by FISH or 3+ IHC; patients who have disease progression while on trastuzumab are eligible; must have been treated w/ a taxane (single agent paclitaxel, docetaxel, or taxane-containing combination chemotherapy) in combination w/ trastuzumab as first or second line chemo for metastatic breast cancer; patients who were maintained on single agent trastuzumab after response or stable disease to previous taxane/trastuzumab combo therapy are eligible; must be off trastuzumab treatment at least 28 days prior to registration; must have measurable or non-measurable disease; must not have effusions or ascites as the only sites of disease; must not have leptomeningeal disease or lymphatic pulmonary metastases; must not have received more than 2 prior chemo regimens for metastatic disease; adjuvant/neoadjuvant chemo for a total of 3 prior regimens, ok; must not have had prior therapy w/ vinorelbine; must not have received other therapy (hormonal or chemo) after progression on a taxane/trastuzumab regimen; must have have received a cumulative dose of > 360 mg/m2 of anthracycline-based chemo; may have received any number or type of exogenous hormonal therapies, either for Stage IV disease and/or as adjuvant therapy; may recieve concomitant bisphosphonate therapy for bone metastasis; must have recovered from any prior surgery (2 weeks from time of minor surgery and 4 weeks from time of major surgery); must not have received radiation to >50% of the marrow-bearing bone; must not have a history of significant symptomatic cardiac disease or left ventricular fraction (LVEF)< 50% of the ILLN; serum creatinine <= 2 mg/dL, calcium <=11 mg/dL, bilirubin <=2 mg/dL, SGPT/SGOT <= 2.5 X IULN or <5 X IULN in the presence of liver metastasis; alk phosph <= 3 x IULN or <5 X IULN in the presence of live or bone metastasis; PS=0-1; must not have pre-existing clinically significant motor or sensory neuropathy except for abnormalities due to cancer; patient w/ brain metastases must have stable disease for more than 3 months after completing radiotherapy to the brain; must not be pregnant or nursing; no other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease free for 5 years.