Clinical trial · Interventional
Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression
- 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 use 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. PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or 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 ditartrate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable or metastatic non-small cell lung cancer * Stage IIIB or IV (closed to accrual as of 4/16/01) OR * Histologically confirmed locally advanced breast cancer that has progressed after first-line chemotherapy or metastatic breast cancer * HER-2/neu overexpression (1+ to 3+) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * ALT no greater than 3 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * No prior or concurrent unstable angina * No prior symptomatic congestive heart failure * No myocardial infarction within the past 6 months * LVEF at least 45% by echocardiogram or MUGA if received prior anthracycline or anthrapyrazole therapy Other: * No prior hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of these products * No other medical illness that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * See Disease Characteristics * No prior vinorelbine Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
Data not yet available