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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AI plus Dimethyldiguanide

AI 1 tablet qd plus Dimethyldiguanide 0.5 bid

Group Type EXPERIMENTAL

AI plus Dimethyldiguanide

Intervention Type DRUG

AI 1 tablet per day Dimethyldiguanide 0.5 bid

Aromatase Inhibitor

AI monotherapy

Group Type ACTIVE_COMPARATOR

Aromatase Inhibitor

Intervention Type DRUG

1 tablet per day

Interventions

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AI plus Dimethyldiguanide

AI 1 tablet per day Dimethyldiguanide 0.5 bid

Intervention Type DRUG

Aromatase Inhibitor

1 tablet per day

Intervention Type DRUG

Other Intervention Names

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letrozole or exemestane Dimethyldiguanide letrozole or exemestane

Eligibility Criteria

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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;