Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xichun Hu
• Treatments: Aromatase Inhibitors; Exemestane; Letrozole

Criteria

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；