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Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer


- Determine the 1-year survival of women with HER2-positive stage IV breast cancer
treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim
(G-CSF) support.

- Determine the response rate (complete and partial, confirmed and unconfirmed) in the
subset of patients with measurable disease treated with this regimen.

- Determine the progression-free survival of patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in these

- Obtain tissue blocks for the determination of predictors of response (e.g.,
beta-tubulin mutations) to microtubule interacting agents in this patient population
and for other future studies.

OUTLINE: This is a pilot, multicenter study.

Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on
days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV
over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued
due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab
is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy
with G-CSF support.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5

Inclusion Criteria


- Histologically confirmed stage IV breast cancer

- Metastasis to the ipsilateral supraclavicular lymph nodes allowed

- HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+
staining confirmed in the adjuvant or metastatic setting

- No effusions or ascites as only sites of disease

- No primary or metastatic brain or central nervous system tumor

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


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

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


- Bilirubin normal

- aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times
upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN


- Not specified


- left ventricular ejection fraction normal by multigated radionuclide angiography or
echocardiogram (patients who have received prior anthracycline therapy)

- No clinical evidence or history of cardiomyopathy


- No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except
abnormalities due to cancer

- No prior severe hypersensitivity reaction to docetaxel or other 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 other adequately
treated stage I or II cancer currently in complete remission

- No known sensitivity to E. coli-derived proteins

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- At least 6 months since prior chemotherapy

- Prior anthracycline as adjuvant therapy allowed

- No prior cumulative dose of doxorubicin more than 360 mg/m^2

- No prior cumulative dose of epirubicin more than 720 mg/m^2

- No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease

- No prior docetaxel

- No prior vinorelbine

- Prior paclitaxel allowed

Endocrine therapy:

- Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer 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:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 1 Year

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Joseph J. Kash, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edward Hospital Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2002

Completion Date:

January 2012

Related Keywords:

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



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