SWOG clinical trial number
S0102
Docetaxel and Vinorelbine Plus Filgrastim for HER-2 Negative, Stage IV Breast Cancer, Phase II
Closed
Phase
Accrual
100%
Published
Research committees
Breast Cancer
Treatment
Docetaxel
Filgrastim
Vinorelbine tartrate
Eligibility Criteria Expand/Collapse
Women with Stage IV, HER-2 negative breast cancer; tumor pathology and HER-2 status microscopically confirmed in the adjuvant or metastatic setting; no more than one prior adjuvant regimen primary disease; no prior taxane; prior hormonal therapy OK; all prior chemotherapy must be completed at least six months before registration; any prior surgery must have been completed at least 2 weeks prior to registration; prior RT OK but must have been completed at least 3 weeks prior to registration; no prior malignancy is allowed except 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 complete remission, or any other cancer from which the patient has been disease-free for 5 years; ANC >= 1,500; platelets >= 100,000; total bilirubin <= IULN, SGOT/SGPT <= 1.5 x IULN and alk phos <= 2.5 x IULN; 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.
Publication Information Expand/Collapse
2016
PMid: PMID27325863 | PMC number: PMC5012713
2014
PMid: PMID24352574 | PMC number: PMC3889983
2007
Expression of the microtubule-associated protein, tau, predicts improved survival, but not response, to a combination of docetaxel and vinorelbine in HER-2 negative metastatic breast cancer
2005
SWOG S0102: a phase II study of docetaxel (DOC) and vinorelbine (VNR) + filgrastim for HER-2 negative, stage IV breast cancer
HIGH expression of the microtubule-associated protein, tau, strongly predicts improved progression free and overall survival in patients with metastatic HER-2 negative breast cancers treated with docetaxel and vinorelbine plus filgrastim
Other Clinical Trials
SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
1%
Open
Phase
SWOG Clinical Trial Number
S2212
TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Research Committee(s)
Breast Cancer
Activated
07/21/2023
Accrual
5%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-BR007
A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer
Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase