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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00250874
Other study ID # Myocet 008 (L017)
Secondary ID
Status Recruiting
Phase Phase 2
First received November 7, 2005
Last updated November 7, 2005
Start date December 2003

Study information

Verified date November 2005
Source Zeneus Pharma
Contact Professor Amadori
Phone +39 0543 731737
Email segronco@ausl.fo.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab


Locations

Country Name City State
Italy Ospedale Pietrantoni Forli

Sponsors (1)

Lead Sponsor Collaborator
Zeneus Pharma

Country where clinical trial is conducted

Italy, 

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