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A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

2014-07-24 14:05:46 | BioPortfolio

Summary

The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.

Description

This is a prospective, non-comparative, non interventional study (NIS) in six hundred (600) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a

Study Design

Time Perspective: Prospective

Conditions

Invasive Early Breast Cancer

Intervention

Aromasin

Status

Enrolling by invitation

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:05:46-0400

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