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
  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:


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: June 2015
Estimated Primary Completion Date: June 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654185

Locations
China
Fudan University Cancer Hospital
Shanghai, China, 200032
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: December 23, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Aromatase Inhibitors
Exemestane
Letrozole
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015