NCT00784940

Brief Summary

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_3

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

June 1, 1998

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

6.8 years

First QC Date

November 3, 2008

Last Update Submit

April 24, 2009

Conditions

Bone Density

Outcome Measures

Primary Outcomes (2)

  • Time to withdrawal

  • Time to recurrence

Study Arms (3)

1

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex placebo

Drug: Anastrozole

2

ACTIVE COMPARATOR

Arimidex placebo + Nolvadex 20mg

Drug: AnastrozoleDrug: Tamoxifen

3

ACTIVE COMPARATOR

Arimidex 1mg + Nolvadex 20mg

Drug: Tamoxifen

Interventions

AnastrozoleDRUG

1mg, orally, once daily

Also known as: Arimidex
12
TamoxifenDRUG

20mg, orally, once daily

Also known as: Nolvadex
23

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for entry into the main ATAC trial 1033IL/0029
  • Women defined as post-menopausal
  • Patients with histologically proven operable invasive breast cancer
  • Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

You may not qualify if:

  • Excluded from entry into the main ATAC trial (1033IL/0029)
  • Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
  • Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
  • Patients who have had a bone fracture within the previous 6 months prior to randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AnastrozoleTamoxifen

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

June 1, 1998

Primary Completion

March 1, 2005

Study Completion

April 1, 2007

Last Updated

April 27, 2009

Record last verified: 2009-04