ATAC - Quality of Life Sub-Protocol

AstraZeneca308 enrolled

Overview

To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

308

Conditions

Quality of Life

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 * Completion of a baseline questionnaire Exclusion Criteria: * Excluded from entry into the main ATAC trial (1033IL/0029) * If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Outcomes

Primary Outcomes

Time to withdrawal

Time to recurrence

Data from ClinicalTrials.gov

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