Metastatic Breast Cancer
Conditions
Brief summary
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.
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.
Interventions
DRUGAI plus Dimethyldiguanide
AI 1 tablet per day Dimethyldiguanide 0.5 bid
DRUGAromatase Inhibitor
1 tablet per day
Sponsors
Xichun Hu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 9 months |
Countries
China
Outcome results
None listed