NCT00537771

Brief Summary

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Sep 2007

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

16 active sites

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

September 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 25, 2013

Completed
Last Updated

January 25, 2013

Status Verified

December 1, 2012

Enrollment Period

4.3 years

First QC Date

September 27, 2007

Results QC Date

December 20, 2012

Last Update Submit

December 20, 2012

Conditions

Breast Cancer

Keywords

Early Breast canceradjuvant therapyhormone receptorhormonal therapyanastrozoletamoxifen

Outcome Measures

Primary Outcomes (1)

  • Incidence of Fatty Liver Disease

    The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

    At 48 weeks, 96 weeks, 144 weeks

Secondary Outcomes (2)

  • Incidence of Abnormal Liver Function

    At 48 weeks, 96 weeks, 144 weeks

  • Time to Treatment Failure

    Within 3 years

Study Arms (2)

1

EXPERIMENTAL

Anastrozole (ARIMIDEX)

Drug: Anastrozole

2

ACTIVE COMPARATOR

Tamoxifen

Drug: Tamoxifen

Interventions

AnastrozoleDRUG

1 mg once daily oral dose

Also known as: ARIMIDEX, ZD1033
1
TamoxifenDRUG

20 mg once daily oral dose

Also known as: NOLVADEX
2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven HR+ invasive breast cancer
  • Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
  • Postmenopausal woman

You may not qualify if:

  • clinical evidence of metastatic disease
  • previous adjuvant hormonal therapy for breast cancer
  • liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Fuzhou, Fujian, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Nanning, Guangxi, China

Location

Research Site

Wuchang, Hubei, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Dalian, Liaoning, China

Location

Research Site

Jinan, Shandong, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Taiyuan, Shanxi, China

Location

Research Site

Xian, Shanxi, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Kunming, Yunnan, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Tianjin, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
James J. Armbrust
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
+44 1625 518062

Study Officials

  • Vivian Gu

    AstraZeneca

    STUDY DIRECTOR

  • Fengping Liang

    AstraZeneca

    STUDY CHAIR

  • Prof. Wang Shenming

    AstraZeneca

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2007

First Posted

October 1, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 25, 2013

Results First Posted

January 25, 2013

Record last verified: 2012-12

Locations

CN(16)