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Clinical Trial Summary

This is a multi-center, retrospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate E2 suppressive effect of Zoladex® 10.8 mg is non-inferior to Zoladex® 3.6 mg. Eligible breast cancer patients who received Zoladex® from January 1st, 2015 till the end of the completion of study data collection (study period) will be identified and included for retrospective data collection and analyses in this study. The first date of the presence of Zoladex® treatment or prescription record for breast cancer during the study period will be considered the index date for patients. According to the Zoladex® treatment at the index date, patients will be categorized into two cohorts: Zoladex® 10.8 mg or Zoladex® 3.6 mg. About 10-15 hospitals will be included in this study. To be considered, the hospitals needs to have relatively large number of eligible patients, geographic representativeness and willingness to participate in this study. All eligible patients from selected hospitals during the study period will be included and matched with propensity scores. It is expected that at least 150 matched patients in each of the two cohorts will eventually be included in the primary endpoint analysis. It is estimated that, during the study period, approximately 10,000 patients had received either 3.6 mg or 10.8 mg of Zoladex® for breast cancer in 10-15 selected hospitals; about 1,000 patients might be eligible to be included in this study. The final subject number will be based on the actual situation of the study.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05184257
Study type Observational
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Recruiting
Start date January 6, 2022
Completion date August 31, 2022

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