Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer
This trial is active, not recruiting.
|Condition||metastatic breast cancer|
|Treatments||ai plus dimethyldiguanide, aromatase inhibitor|
|Start date||July 2012|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01654185, Fudan BR2012-12|
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
progression free survival
time frame: 9 months
Female participants at least 18 years old.
Inclusion Criteria: - postmenopausal HR positive breast cancer patients; - inoperable locally advanced or metastatic breast cancer patients; - candidate for endocrine therapy; - ECOG equal to or less than 1; - adequate bone marrow function(Hb>=90g/L, WBC >=3.5×10^9/L,ANC>=1.5×10^9/L, PLT>=80×10^9/L; adequate renal function(Ccr<=ULN);adequate liver function(ALT,AST,AKP<=2.5*ULN,or <=5*ULN if liver metastases) - life expectancy >=12weeks; - no severe history disease of liver,heart,lung or kidney; - written informed consent form; Exclusion Criteria: - Her-2 overexpression; - patients who has visceral endocrisis；
|Official title||Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.|
|Principal investigator||Xichun Hu, MD,PhD|
|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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