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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Zeneus Pharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zeneus Pharma
ClinicalTrials.gov Identifier:
NCT00250874
First received: November 7, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zeneus Pharma:

Estimated Enrollment: 45
Study Start Date: December 2003
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250874

Contacts
Contact: Professor Amadori +39 0543 731737 segronco@ausl.fo.it
Contact: Professor Gasparini

Locations
Italy
Ospedale Pietrantoni Recruiting
Forli, Italy
Principal Investigator: Professor Amadori            
Sponsors and Collaborators
Zeneus Pharma
Investigators
Principal Investigator: Professor Amadori Ospedale Pietrantoni, Forli, Italy
Principal Investigator: Professor Gasparini San Filippo Neri, Rome, Italy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250874     History of Changes
Other Study ID Numbers: Myocet 008 (L017)
Study First Received: November 7, 2005
Last Updated: November 7, 2005
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
 Docetaxel
Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013