Clinical trial · Interventional
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
NCT00433095CI-TRIAL-00004561completedPhase 2ClinicalTrials.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)
1st-line treatment of HER2/neu overexpressing 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 |
|---|---|---|---|
| Carcinoma Breast Stage IV | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
| Navelbine | Drug | Vinorelbine | ALIAS |
| Navelbine (oraly) | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (3)
- measure
- Time to tumor progression
- measure
- Overall survival
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, metastatic breats cancer. * HER2-neu overexpression (IHC3+ or IHC2+/FISH+) * Written informed consent * no previous therapy with vinorelbine or trastuzumab * Age \* 18 and \* 75 years * Karnofsky-Performance status \> 70% * Life expectance 16 weeks and more * Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions * Exclusion of pregnancy and adequte contraception during childbearing age. * Adequate hematological, renal, and hepatic function * Normal cardiac function. LVEF should not be \>10% below normal. * Adequate compliance to perform treatment and subsequent follow-up visits Exclusion Criteria: * Locoregional recurrence of breast cancer only or development of contralateral breast cancer * Pregnancy or lactation * Symptomatic brain- or meningeal metastasis * Concurrent endocrine antitumor therapy * Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix * Peripheral neuropathy \>= NCI CTC Grade 2. * other severel disease which preclude adequate treatment * Participation in a clinical trial within the last 30 days. * Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.