This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments ai plus dimethyldiguanide, aromatase inhibitor
Phase phase 2
Sponsor Xichun Hu
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
ai plus dimethyldiguanide letrozole or exemestane
AI 1 tablet per day Dimethyldiguanide 0.5 bid
(Active Comparator)
AI monotherapy
aromatase inhibitor letrozole or exemestane
1 tablet per day

Primary Outcomes

progression free survival
time frame: 9 months

Eligibility Criteria

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;

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fudan University.