S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF). Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen. Determine the qualitative and quantitative toxic effects of this regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.

Official Title
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Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: docetaxel
* Drug: vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>docetaxel and vinorelbine with filgrastim support | Biological: filgrastim<br> <br> Drug: docetaxel<br> <br> Drug: vinorelbine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer