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

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- Histologically confirmed stage IV carcinoma of the breast

- HER-2 negative

- 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization [FISH]

- 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



- Not specified


- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Not specified


- 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


Biologic therapy:

- Not specified


- 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


- At least 3 weeks since prior radiotherapy


- At least 2 weeks since prior surgery and recovered

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Julie R. Gralow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



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