Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
Type: Drug
Overall Status
Recruiting
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 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Ospedale Pietrantoni
Forli, Italy
Status: Recruiting
Start Date
December 2003
Sponsors
Zeneus Pharma
Source
Zeneus Pharma
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page