Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0215 S0215, NCT00041067

Objectives

1. 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.
2. Determine the response rate (complete and partial, confirmed and unconfirmed) in the subset of patients with measurable disease treated with this regimen.
3. Determine the progression-free survival of patients treated with this regimen.
4. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
5. 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.

Entry Criteria

Disease Characteristics:

• 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 CNS tumor



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 months since prior chemotherapy
• Prior anthracycline as adjuvant therapy allowed
• No prior cumulative dose of doxorubicin more than 360 mg/m²
• No prior cumulative dose of epirubicin more than 720 mg/m²
• 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

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• At least 2 weeks since prior surgery and recovered

Patient Characteristics:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin normal
• AST or ALT no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Not specified

Cardiovascular:

• LVEF normal by MUGA or echocardiogram (patients who have received prior anthracycline therapy)
• No clinical evidence or history of cardiomyopathy

Other:

• 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

Expected Enrollment

A total of 90 patients will be accrued for this study within 18-22.5 months.

Outcomes

Survival at 1 year
Toxicity

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.

Kash J, Barlow WE, Albain KS, et al.: Phase II Southwest Oncology Group study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-1033, 2008.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Joseph Kash, MD, Protocol chair		Ph: 630-527-3788

Registry Information
Official Title		Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer
Trial Start Date		2002-09-15
Registered in ClinicalTrials.gov		NCT00041067
Date Submitted to PDQ		2002-05-10
Information Last Verified		2007-01-01
NCI Grant/Contract Number		CA32102

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