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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
February 17, 2006
February 22, 2006
March 31, 2009
January 2006
Not Provided
Progression-Free Survival
  • Response Rate
  • Progression-Free Survival
Complete list of historical versions of study NCT00294996 on ClinicalTrials.gov Archive Site
  • Overall Survival
  • Safety
Same as current
Not Provided
Not Provided
 
Trial of Myocet in Metastatic Breast Cancer
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Myocet
Not Provided
Baselga J, Manikhas A, Cortés J, Llombart A, Roman L, Semiglazov VF, Byakhov M, Lokanatha D, Forenza S, Goldfarb RH, Matera J, Azarnia N, Hudis CA, Rozencweig M. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER2-positive metastatic breast cancer. Ann Oncol. 2014 Mar;25(3):592-8. doi: 10.1093/annonc/mdt543. Epub 2014 Jan 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
363
Not Provided
Not Provided

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Germany,   India,   Italy,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom,   United States
 
 
NCT00294996
STM01-102
Not Provided
Not Provided
Not Provided
Not Provided
Sopherion Therapeutics
Not Provided
Principal Investigator: Jose Baselga, M.D. Vall d'Hebron Hospital, Barcelona, Spain
Sopherion Therapeutics
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP