Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer

NCT00103233 | Completed Phase 3

• 2 other identifiers: CDR0000409573SWOG-S0347
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab may also help vinorelbine work better by making tumor cells more sensitive to the drug. Giving vinorelbine together with trastuzumab may be an effective treatment for breast cancer. It is not yet known whether giving vinorelbine together with trastuzumab is more effective than vinorelbine alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying vinorelbine and trastuzumab to see how well they work compared to vinorelbine alone in treating women with progressive metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

trastuzumab BIOLOGICAL

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Lajos Pusztai, MD, MPH, DPhil

  M.D. Anderson Cancer Center

• Francisco J. Esteva, MD

  M.D. Anderson Cancer Center

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: December 1, 2004
• Study Completion: April 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2005-08