NCT01654185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 14, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

July 27, 2012

Last Update Submit

March 13, 2017

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    9 months

Study Arms (2)

AI plus Dimethyldiguanide

EXPERIMENTAL

AI 1 tablet qd plus Dimethyldiguanide 0.5 bid

Drug: AI plus Dimethyldiguanide

Aromatase Inhibitor

ACTIVE COMPARATOR

AI monotherapy

Drug: Aromatase Inhibitor

Interventions

AI plus DimethyldiguanideDRUG

AI 1 tablet per day Dimethyldiguanide 0.5 bid

Also known as: letrozole or exemestane, Dimethyldiguanide
AI plus Dimethyldiguanide
Aromatase InhibitorDRUG

1 tablet per day

Also known as: letrozole or exemestane
Aromatase Inhibitor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Her-2 overexpression;
  • patients who has visceral endocrisis；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LetrozoleexemestaneAromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of Drugs

Study Officials

  • Xichun Hu, MD,PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy director of department of medical oncology

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2016

Last Updated

March 14, 2017

Record last verified: 2017-01

Locations

CN(1)