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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: AI plus Dimethyldiguanide; Drug: Aromatase Inhibitor

• Registration Number: NCT01654185
• Lead Sponsor: Xichun Hu

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Primary Completion: 2014-07
• Study Completion: 2016-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI plus Dimethyldiguanide	AI plus Dimethyldiguanide	AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
Aromatase Inhibitor	Aromatase Inhibitor	AI monotherapy

Primary Outcome Measures

Name	Time	Method
progression free survival	9 months

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China