SWOG clinical trial number
S0215

Docetaxel and Vinorelbine Plus Filgrastim with Weekly Trastuzumab for HER-2 Positive, Stage IV Breast Cancer, Phase II Pilot

Closed
Phase
Accrual
84%
Published
Abbreviated Title
ADVANCED: Doxetaxel/Vinorelbine/Filgrastim for HER-2 Pos Stage IV Breast Cancer
Activated
09/15/2002
Closed
01/01/2007
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Breast Cancer

Treatment

Docetaxel Filgrastim Trastuzumab Vinorelbine tartrate

Eligibility Criteria Expand/Collapse

Women with Stage IV, HER-2 positive breast cancer; HER-2 status confirmed by FISH in the adjuvant or metastatic setting; no more than one prior adjuvant or neoadjuvant regimen; no prior docetaxel therapy (paclitaxel is allowed); no prior vinorelbine; prior hormonal therapy OK but must be stopped prior to registration; all prior chemotherapy must be completed at least six months before registration; prior RT OK but must have been completed at least 3 weeks prior to registration; no brain or CNS disease or evidence of brain or CNS metastases; no pre-existing >= Grade 2 motor or sensory peripheral neruopathy except for abnormalities due to cancer; no know sensitivity to E. coli derived proteins; no history of severe hypersensitivity to drugs formulated with polysorbate 80; no pregnant or nursing women. PS 0-2; Prior cummulative doxorubicin dose of <=360 mg/m2; prior cummulative epirubicin dose of <=720mg/m2; No evidence or history of cardiomyopathy.

Publication Information Expand/Collapse

2011

SWOG S0215: A phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast [PMID21826527;PMC3513946]

R Livingston;W Barlow;J Kash;K Albain;J Gralow;D Lew;L Flaherty;ME Royce;GN Hortobagyi Breast Cancer Research and Treatment 130(1):123-131;

2008

Phase II Southwest Oncology Group study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer

J Kash;WE Barlow;KS Albain;JR Gralow;D Lew;LE Flaherty;ME Royce;GN Hortobagyi;RB Livingston Journal of Clinical Oncology 26(15S):49s, #1033