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

This study is currently recruiting participants.
Verified March 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01654185
First received: July 27, 2012
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: AI plus Dimethyldiguanide
Drug: Aromatase Inhibitor
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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；
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654185

Contacts
Contact: Xichun Hu, MD, PhD 64175590 ext 5006 huxicun@gmail.com
Contact: Biyun Wang, MD 64175590 ext 5000 wangbiyun@msn.com

Locations
China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD     64175590 ext 5006     huxicun@gmail.com    
Contact: Biyun Wang, MD     64175590 ext 5000     wangbiyun@msn.com    
Sponsors and Collaborators
Xichun Hu
Investigators
Principal Investigator: Xichun Hu, MD,PhD Fudan University
  More Information

No publications provided

Responsible Party: Xichun Hu, Deputy director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT01654185     History of Changes
Other Study ID Numbers: Fudan BR2012-12
Study First Received: July 27, 2012
Last Updated: March 29, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Letrozole
 Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013