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Trial of Myocet in Metastatic Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Sopherion Therapeutics.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294996
First Posted: February 22, 2006
Last Update Posted: March 31, 2009
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.
Information provided by:
Sopherion Therapeutics
  Purpose
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.

Condition Intervention Phase
Breast Cancer Drug: Myocet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sopherion Therapeutics:

Primary Outcome Measures:
  • Progression-Free Survival

Secondary Outcome Measures:
  • Overall Survival
  • Safety

Enrollment: 363
Study Start Date: January 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic Her2+ Breast cancer by FISH analysis
  • No prior chemotherapy for metastatic disease
  • Measurable disease
  • normal left ventricular ejection fraction

Exclusion Criteria:

  • prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
  • relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00294996


  Show 105 Study Locations
Sponsors and Collaborators
Sopherion Therapeutics
Investigators
Principal Investigator: Jose Baselga, M.D. Vall d'Hebron Hospital, Barcelona, Spain
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294996     History of Changes
Other Study ID Numbers: STM01-102
First Submitted: February 17, 2006
First Posted: February 22, 2006
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by Sopherion Therapeutics:
Metastatic Her2+ Breast cancer
Myocet
liposomal doxorubicin
trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action