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NCT05184257

Zoladex® 10.8 BC RWS

Completed Last updated 23 January 2025
What this trial tests

trial in Breast Cancer in 1,176 participants. Completed in 15 December 2023.

Timeline
6 January 2022
Primary endpoint
15 December 2023
15 December 2023

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,176
Start date6 January 2022
Primary completion15 December 2023
Estimated completion15 December 2023
Sites16 locations across China

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Real-world effectiveness of goserelin 10.8-mg compared to goserelin 3.6-mg in premenopausal and perimenopausal Chinese patients with hormone receptor positive breast cancer: a cohort study.
    Wang Y, Wang X, Wu J, Liu H, et al · · 2025 · cited 1× · PMID 40814439 · DOI 10.1016/j.jncc.2025.02.006

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Other recruiting trials for Breast Cancer

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05184257.

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