drugset / Trial / NCT01176916

Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

NCT01176916

Phase 4 Completed 564 enrolled Pfizer
Open-label

Summary

Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen \& are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

Timeline

Start
2011-02-09
Primary completion
2018-11-30
Completion
2018-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Exemestane Small molecule

Indications