Zoladex® 10.8 BC RWS

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05184257
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study Start: 2022-01-06
• Study First Posted: 2022-01-11
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	serum E2 suppression at 12 weeks (±4 weeks) after Zoladex® treatment	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.

Secondary Outcome Measures

Name	Time	Method
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	serum E2 suppression at 24 weeks (±4 weeks) after Zoladex®	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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Xining, China