ATAC - Bone Density Sub-Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arimidex 1mg + Nolvadex placebo

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

2

Arimidex placebo + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1mg, orally, once daily

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

3

Arimidex 1mg + Nolvadex 20mg

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20mg, orally, once daily

Interventions

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Anastrozole

1mg, orally, once daily

Intervention Type DRUG

Tamoxifen

20mg, orally, once daily

Intervention Type DRUG

Other Intervention Names

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Arimidex Nolvadex

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No