ATAC - Bone Density Sub-Protocol

AstraZeneca308 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

308

Conditions

Bone Density

Interventions

AnastrozoleDRUG

1mg, orally, once daily

TamoxifenDRUG

20mg, orally, once daily

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to withdrawal

Time to recurrence

Data from ClinicalTrials.gov

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