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
Recruitment status was Active, not recruiting
Sponsor:
Sopherion Therapeutics
Information provided by:
Sopherion Therapeutics
ClinicalTrials.gov Identifier:
NCT00294996
First received: February 17, 2006
Last updated: March 30, 2009
Last verified: March 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 17, 2006 | ||||
| Last Updated Date | March 30, 2009 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Progression-Free Survival | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00294996 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Myocet in Metastatic Breast Cancer | ||||
| Official Title ICMJE | A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Drug: Myocet | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 363 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Argentina, Canada, Germany, India, Italy, Poland, Portugal, Russian Federation, Spain, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00294996 | ||||
| Other Study ID Numbers ICMJE | STM01-102 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Sopherion Therapeutics | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sopherion Therapeutics | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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