Clinical trial · Interventional
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
NCT00250874CI-TRIAL-00000201unknownPhase 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)
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test * Female \< 70yrs * Histologically or cytologically proven breast cancer. * Metastatic or locally advanced breast cancer (clinical stage: III-IV) * Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50% * Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2 Exclusion Criteria: * History of cardiopathy * Severe hepatic and renal diseases * Brain metastases as the only parameter of disease * Contraindication to the use of corticosteroids as premedication * Acute infectious diseases * Insulin-dependent diabetes * History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix * Concurrent treatment with any other cancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.