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 therapy in patients affected by HER-2/neu positive metastatic breast cancer
2. To enhance the proportion of complete remission
3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
