Status:
COMPLETED
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodi...
Detailed Description
OBJECTIVES: * Compare progression-free survival (PFS) of women with HER2-positive progressive metastatic breast cancer treated with vinorelbine with or without trastuzumab (Herceptin®). * Compare ove...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Clinical evidence of metastatic disease
- HER2-positive tumor, as indicated by one of the following methods:
- HER2 gene amplification by fluorescence in situ hybridization
- HER2 protein overexpression (3+) by immunohistochemistry
- Disease progression during or after prior taxane therapy (single-agent paclitaxel, docetaxel, or taxane-containing combination chemotherapy) in combination with trastuzumab (Herceptin®) as first- or second-line chemotherapy for metastatic disease
- Patients who received maintenance therapy with single-agent trastuzumab after acheiving a response or stable disease to prior taxane/trastuzumab combination therapy are eligible provided disease has progressed
- Measurable or nonmeasurable disease
- No effusions or ascites as the only sites of disease
- No leptomeningeal disease or lymphatic pulmonary metastases
- Brain metastases allowed provided disease is stable for \> 3 months after completion of prior radiotherapy to the brain
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in the presence of liver metastases)
- Alkaline phosphatase ≤ 3 times ULN (\< 5 times ULN in the presence of liver or bone metastases)
- Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium ≤ 11.0 mg/dL
- Cardiovascular
- No history of significant symptomatic cardiac disease
- LVEF ≥ 50% of the lower limit of normal by MUGA or ECG
- Other
- No pre-existing clinically significant (≥ grade 2) motor or sensory neuropathy except for abnormalities due to cancer
- 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 in complete remission
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- At least 28 days since prior trastuzumab
- No concurrent filgrastim (G-CSF)
- Chemotherapy
- See Disease Characteristics
- No more than 2 prior chemotherapy regimens for metastatic breast cancer
- Prior adjuvant/neoadjuvant chemotherapy allowed, for a total of 3 prior regimens
- No prior vinorelbine
- No other prior chemotherapy after progression on a taxane/trastuzumab regimen
- No prior cumulative dose \> 360 mg/m\^2 of anthracycline-based chemotherapy
- Endocrine therapy
- No prior hormonal therapy after progression on a taxane/trastuzumab regimen
- Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed
- Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to \> 50% of the marrow-bearing bone
- Surgery
- At least 4 weeks since prior major surgery (2 weeks for minor surgery) and recovered
- Other
- Concurrent bisphosphonates allowed for bone metastasis
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00103233
Start Date
December 1 2004
End Date
April 1 2006
Last Update
June 24 2013
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