Abstract
523 Background: Retrospective data show that compliance to adjuvant endocrine therapy for early breast cancer (EBC) may drop below 80% after 1 year and as low as 50% by year 4. PACT aims to increase treatment adherence in postmenopausal women taking adjuvant anastrozole via a standardized information service. Methods: PACT is a prospective, randomised, two-arm parallel group trial with 60 months follow-up. Women on anastrozole for hormone receptor-positive (HR+) EBC were randomized to routine clinical care alone or additional standardized information for the first 12 months of adjuvant therapy. Primary endpoint is the compliance rate after 12 months. Secondary endpoints include reasons for noncompliance, influence of baseline characteristics, and clinical outcome parameters. Compliance is evaluated via patient questionnaires, prescription data and physician recall. Results: 4,924 women were enrolled by November 2008, the average age was 64.7 years. 97.7% were ER+, 8.4% HER2+, mean tumour size 21.4 mm, 74.5% had received breast preserving surgery, 23.5% a mastectomy, 6.7% had had neoadjuvant chemotherapy and almost 40% received adjuvant chemotherapy. 85% were scheduled for adjuvant radiotherapy. Analysis of the primary endpoint compliance at 12 months will be performed after data base lock in February 2010. Conclusions: PACT is the largest prospective trial to date on compliance in HR+ EBC and aims to clarify whether standardized information services throughout year one may improve compliance to adjuvant endocrine treatment and influence outcomes in postmenopausal women with HR+ EBC. Sponsored by AstraZeneca. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca, Roche AstraZeneca
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