Zoladex® 10.8 BC RWS

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 1176

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Research site
  • Changsha, China, 410013
    • Research site
  • Chengdu, China
    • Research site
  • Guangan, China
    • Research site
  • Guangyuan, China
    • Research site
  • Guangzhou, China
    • Research site
  • Guangzhou, China, 510060
    • Research site
  • Hangzhou, China
    • Research site
  • Jinan, China, 250117
    • Research site
  • Nantong, China
    • Research site
  • Shanghai, China, 200032
    • Research site
  • Suzhou, China
    • Research site
  • Suzhou, China, 215006
    • Research site
  • Taiyuan, China
    • Research site
  • Tianjin, China, 300060
    • Research site
  • Xining, China
    • Research site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with premenopausal and perimenopausal breast cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study Drugs; The study drug is Zoladex® 10.8 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.
Comparison Drugs; The comparison drug is Zoladex® 3.6 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	serum E2 suppression at 12 weeks (±4 weeks) after Zoladex® treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	serum E2 suppression at 24 weeks (±4 weeks) after Zoladex®

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D8664R00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No