NCT00015938

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

Official Title:

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

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Breast Cancer

Primary Purpose
  • TREATMENT
Intervention/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
Sponsor
  • SWOG Cancer Research Network