Clinical trial · Interventional
S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer
NCT00041067CI-TRIAL-00010633completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab, docetaxel, vinorelbine and filgrastim
- description
- Trastuzumab, docetaxel, vinorelbine and filgrastim
- interventionNames
- Biological: filgrastim
- Biological: trastuzumab
- Drug: docetaxel
- Drug: vinorelbine
Primary outcomes (1)
- measure
- Survival at 1 Year
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Response Rate (Complete and Partial, Confirmed and Unconfirmed)
- timeFrame
- response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 central nervous system tumor * Hormone receptor status: * Not specified 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/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * 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 Renal: * Not specified Cardiovascular: * 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 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 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/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 Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * At least 2 weeks since prior surgery and recovered
References
Publications (1)
- RESULTLivingston RB, Barlow WE, Kash JJ, Albain KS, Gralow JR, Lew DL, Flaherty LE, Royce ME, Hortobagyi GN. SWOG S0215: a phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer. Breast Cancer Res Treat. 2011 Nov;130(1):123-31. doi: 10.1007/s10549-011-1698-5. Epub 2011 Aug 9. PMID 21826527