Zoladex® 10.8 BC RWS

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with primary breast cancer
Female, ≥18 years old (at index date)
HR positive
Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment
Premenopausal status prior to the treatment of Zoladex®. Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date
At least one actual or expected E2 testing measurement within 8-28 weeks of the index date Exclusion Criteria
Patients received concurrent treatments that may affect E2 testing results

Treatment and study plan

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

The Effectiveness of Zoladex® 10.8 mg Compared to Zoladex® 3.6mg in the Treatment of Premenopausal and Perimenopausal Hormone Receptor Positive Breast Cancer: A Real-World Study

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 11, 2022
Registry last updated: Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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