An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 16 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by AstraZeneca · Observational
This is a multi-center, retrospective-prospective, 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 December 31st, 2021(including December 31st, 2021) will be identified and included for retrospective data collection and analyses in this study. And prospective data will be monthly collected of eligible patients receiving Zoladex® after January 1st, 2022 (including January 1st, 2022) until approximately 1000 patients being included in this study for analysis. (If site has specific identification of retrospective data and prospective data, it will be subject to the requirement of site). 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 need to have relatively large number of eligible patients, geographic representativeness and willingness to participate in this study. Approximately 1000 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. The final subject number will be based on the actual situation of the study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,176 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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Patients with premenopausal and perimenopausal breast cancer
Inclusion Criteria
The study drug is Zoladex® 10.8 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.
The comparison drug is Zoladex® 3.6 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.
Proportion of patients with serum E2 suppression at 12 weeks (±4 weeks). Serum E2 suppression is defined as an E2 value below the upper limit of the menopausal reference range
To assess the E2 suppressive effect of Zoladex® 10.8 mg is non-inferior to Zoladex® 3.6 mg at 12th week for the treatment of patients with premenopausal and perimenopausal breast cancer.
Time frame: serum E2 suppression at 12 weeks (±4 weeks) after Zoladex® treatment
Proportion of patients with serum E2 suppression at 24 weeks (±4 weeks). Serum E2 suppression was defined as an E2 value below the upper limit of the menopausal reference range
To assess the E2 suppressive effect of Zoladex® 10.8 mg and Zoladex® 3.6 mg at 24th week for the treatment of patients with premenopausal and perimenopausal breast cancer
Time frame: serum E2 suppression at 24 weeks (±4 weeks) after Zoladex®
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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