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OpenTrials
Completed

NCT Number: NCT01654185

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Cancer Hospital

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

AI plus Dimethyldiguanide

Drug

AI 1 tablet per day Dimethyldiguanide 0.5 bid

Other names: letrozole or exemestane, Dimethyldiguanide

Aromatase Inhibitor

Drug

1 tablet per day

Other names: letrozole or exemestane

Primary outcomes

  1. progression free survival

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Xichun Hu

Other

Registry information

Official study title

Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jul 31, 2012
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.