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

Metastatic Breast Cancer Clinical Trial

Official title:

Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654185
• Other study ID #: Fudan BR2012-12
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2012
• Last updated: March 13, 2017
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• AI plus Dimethyldiguanide
AI 1 tablet per day Dimethyldiguanide 0.5 bid
• Aromatase Inhibitor
1 tablet per day

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xichun Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		9 months