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

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

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

Study Overview

• Status: Unknown
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab

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

• Study Type: Interventional
• Enrollment: 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Forli, Italy
    • Recruiting
    • Ospedale Pietrantoni
    • Principal Investigator: Professor Amadori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Collaborators and Investigators

• Sponsor: Zeneus Pharma
• Investigators: Principal Investigator: Professor Amadori, Ospedale Pietrantoni, Forli, Italy; Principal Investigator: Professor Gasparini, San Filippo Neri, Rome, Italy

Study record dates

Study Major Dates

• Study Start: December 1, 2003

Study Registration Dates

• First Submitted: November 7, 2005
• First Submitted That Met QC Criteria: November 7, 2005
• First Posted (ESTIMATE): November 8, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2005
• Last Update Submitted That Met QC Criteria: November 7, 2005
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Antibiotics, Antineoplastic; Docetaxel; Trastuzumab; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: Myocet 008 (L017)