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

Xichun Hu

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: AI plus Dimethyldiguanide; Drug: Aromatase Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01654185

Fudan BR2012-12

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

AI plus Dimethyldiguanide

Experimental group

Description:

AI 1 tablet qd plus Dimethyldiguanide 0.5 bid

Treatment:

Drug: AI plus Dimethyldiguanide

Aromatase Inhibitor

Active Comparator group

Description:

AI monotherapy

Treatment:

Drug: Aromatase Inhibitor