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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: AI plus Dimethyldiguanide; Drug: Aromatase Inhibitor

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
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: letrozole or exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression free survival	9 months

Collaborators and Investigators

• Sponsor: Xichun Hu

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Exemestane; Aromatase Inhibitors
• Other Study ID Numbers: Fudan BR2012-12