Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01654185
First received: July 27, 2012
Last updated: December 23, 2014
Last verified: December 2014

July 27, 2012
December 23, 2014
July 2012
June 2015   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
60
June 2015
June 2015   (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;
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01654185
Fudan BR2012-12
Yes
Xichun Hu, Fudan University
Xichun Hu
Not Provided
Principal Investigator: Xichun Hu, MD,PhD Fudan University
Fudan University
December 2014

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