Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeneus Pharma
• Treatments: Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab

Criteria

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