Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer
This study is currently recruiting participants.
Verified July 2012 by Fudan University
Sponsor:
Xichun Hu
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01654185
First received: July 27, 2012
Last updated: July 30, 2012
Last verified: July 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 27, 2012 | ||||||||
| Last Updated Date | July 30, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
progression free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01654185 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer | ||||||||
| Official Title ICMJE | Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer. | ||||||||
| Brief Summary | The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer. |
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| Detailed Description | The addition of dimethyldiguanide might increase the efficacy of AI in patients with metastatic breast cancer after the failure of the first line endocrine therapy. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| 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 | Metastatic Breast Cancer | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01654185 | ||||||||
| Other Study ID Numbers ICMJE | Fudan BR2012-12 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Xichun Hu, Fudan University | ||||||||
| Study Sponsor ICMJE | Xichun Hu | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Fudan University | ||||||||
| Verification Date | July 2012 | ||||||||
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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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