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Tracking Information | |||||||||
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First Received Date † | June 5, 2007 | ||||||||
Last Updated Date | October 30, 2008 | ||||||||
Start Date † | June 2007 | ||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00483223 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response | ||||||||
Official Title † | A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response | ||||||||
Brief Summary | The purpose of this research study is to :
Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from growing abnormally and is used to treat other cancers.
The hypothesis is that Triple Negative metastatic breast cancer may be particularly sensitive to platinum, and that a subgroup of those patients may have a marker in their tumors that predicts response. |
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Detailed Description | This study is a Phase 2 study designed to evaluate cisplatin/carboplatin as first or second line therapy in metastatic triple negative (ER negative, PR negative, Her2 Negative) breast cancer and to evaluate the expression of p63/p73 as a biomarker to predict response.
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Breast Cancer | ||||||||
Intervention † |
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Study Arms / Comparison Groups | Experimental: Cisplatin or carboplatin (1 arm, 2 cohorts) | ||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 82 | ||||||||
Estimated Completion Date | June 2010 | ||||||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00483223 | ||||||||
Responsible Party | Steven Isakoff, MD, PhD, Massachusetts General Hospital | ||||||||
Secondary IDs †† | TBCRC009 | ||||||||
Study Sponsor † | Massachusetts General Hospital | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | Massachusetts General Hospital | ||||||||
Verification Date | October 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |