Status:
UNKNOWN
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Lead Sponsor:
Zeneus Pharma
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
Detailed Description
1. To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00250874
Start Date
December 1 2003
Last Update
November 8 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Pietrantoni
Forlì, Italy