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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250874
Recruitment Status : Unknown
Verified November 2005 by Zeneus Pharma.
Recruitment status was:  Recruiting
First Posted : November 8, 2005
Last Update Posted : November 8, 2005
Information provided by:
Zeneus Pharma

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab Phase 2

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  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250874

Contact: Professor Amadori +39 0543 731737
Contact: Professor Gasparini

Ospedale Pietrantoni Recruiting
Forli, Italy
Principal Investigator: Professor Amadori         
Sponsors and Collaborators
Zeneus Pharma
Principal Investigator: Professor Amadori Ospedale Pietrantoni, Forli, Italy
Principal Investigator: Professor Gasparini San Filippo Neri, Rome, Italy Identifier: NCT00250874     History of Changes
Other Study ID Numbers: Myocet 008 (L017)
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: November 8, 2005
Last Verified: November 2005

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors