This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01654185
First received: July 27, 2012
Last updated: March 13, 2017
Last verified: January 2017
July 27, 2012
March 13, 2017
July 2012
July 2014   (Final data collection date for primary outcome measure)
progression free survival [ Time Frame: 9 months ]
Same as current
Complete list of historical versions of study NCT01654185 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer
Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: AI plus Dimethyldiguanide
    AI 1 tablet per day Dimethyldiguanide 0.5 bid
    Other Names:
    • letrozole or exemestane
    • Dimethyldiguanide
  • Drug: Aromatase Inhibitor
    1 tablet per day
    Other Name: letrozole or exemestane
  • Experimental: AI plus Dimethyldiguanide
    AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
    Intervention: Drug: AI plus Dimethyldiguanide
  • Active Comparator: Aromatase Inhibitor
    AI monotherapy
    Intervention: Drug: Aromatase Inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2016
July 2014   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01654185
Fudan BR2012-12
Yes
Not Provided
Not Provided
Xichun Hu, Fudan University
Xichun Hu
Not Provided
Principal Investigator: Xichun Hu, MD,PhD Fudan University
Fudan University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP