Clinical trial · Interventional
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy - Phase III
- 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, 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
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab | Biological | Trastuzumab | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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