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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654185
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: AI plus Dimethyldiguanide Drug: Aromatase Inhibitor Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.
Study Start Date : July 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AI plus Dimethyldiguanide
AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
Drug: AI plus Dimethyldiguanide
AI 1 tablet per day Dimethyldiguanide 0.5 bid
Other Names:
  • letrozole or exemestane
  • Dimethyldiguanide
Active Comparator: Aromatase Inhibitor
AI monotherapy
Drug: Aromatase Inhibitor
1 tablet per day
Other Name: letrozole or exemestane

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01654185

Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Xichun Hu
Principal Investigator: Xichun Hu, MD,PhD Fudan University

Responsible Party: Xichun Hu, Deputy director of department of medical oncology, Fudan University Identifier: NCT01654185     History of Changes
Other Study ID Numbers: Fudan BR2012-12
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs