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

Metastatic Breast Cancer Clinical Trial

Official title:

Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00250874
• Other study ID #: Myocet 008 (L017)
• 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
• 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

• Breast Neoplasms
• Metastatic Breast Cancer

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,