At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN
In Brief
A Phase 4 clinical trial evaluating Aromasin (exemestane) for Breast Neoplasms. Completed, enrolled 564 participants across 53 sites.
Detailed 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.
Study Details
Timeline
Interventions
the dosage, frequency and duration base on the LPD approved by SFDA.