Trial of Myocet in Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sopherion Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sopherion Therapeutics
ClinicalTrials.gov Identifier:
NCT00294996
First received: February 17, 2006
Last updated: March 30, 2009
Last verified: March 2009

February 17, 2006
March 30, 2009
January 2006
Not Provided
Progression-Free Survival
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   India,   Italy,   United States,   United Kingdom,   Argentina,   Poland,   Germany,   Spain,   Russian Federation,   Portugal
 
NCT00294996
STM01-102
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