Zoladex® 10.8 BC RWS

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184257
• Other study ID #: D8664R00002
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1176
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Guangan
China	Research Site	Guangyuan
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Jinan
China	Research Site	Nantong
China	Research Site	Shanghai
China	Research Site	Suzhou
China	Research Site	Suzhou
China	Research Site	Taiyuan
China	Research Site	Tianjin
China	Research Site	Xining

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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®