NCT00015938
S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
PHASE2
COMPLETED
NCT00015938
INTERVENTIONAL
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV carcinoma of the breast
* HER-2 negative
* 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization \[FISH\] negative)
* Weak or no staining on immunohistochemistry test
* No amplification by FISH
* No effusions or ascites as only site of disease
* No brain or CNS disease or metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Not specified
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Zubrod 0-2
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Not specified
Other:
* No clinically significant pre-existing grade 2 or greater motor or sensory peripheral neuropathy unless due to cancer
* No known sensitivity to E. coli-derived proteins
* No prior severe hypersensitivity reaction to drugs formulated with polysorbate 80
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy other than 1 prior adjuvant or neoadjuvant chemotherapy program for primary disease
* At least 6 months since prior chemotherapy
* Prior adjuvant anthracycline allowed
* No prior taxanes (docetaxel or paclitaxel)
Endocrine therapy:
* Prior adjuvant hormonal therapy for metastatic disease allowed
* No concurrent hormonal therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy
Surgery:
* At least 2 weeks since prior surgery and recovered
Breast Cancer
- TREATMENT
-
- Type: BIOLOGICAL
- Name: filgrastim
- Description:
- Arm Group Labels: treatment
-
- Type: DRUG
- Name: docetaxel
- Description:
- Arm Group Labels: treatment
-
- Type: DRUG
- Name: vinorelbine
- Description:
- Arm Group Labels: treatment
- SWOG Cancer Research Network