Study identifier:D8666C00004
ClinicalTrials.gov identifier:NCT03658213
EudraCT identifier:N/A
CTIS identifier:N/A
An Open Label, Randomised, Parallel Group, Multicentre, Non-inferiority Study to Compare ZOLADEX 10.8 mg with ZOLADEX 3.6 mg in Chinese Pre-menopausal Patients with Estrogen Receptor-Positive and HER2 Negative Early Breast Cancer
Breast Cancer
Phase 3
No
ZOLADEX 10.8 mg, ZOLADEX 3.6mg
Female
0
Interventional
18 Years - 59 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2021 by AstraZeneca
AstraZeneca
-
This study will recruit 168 patients in approximately 20 study centres in China. The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
This study will recruit 168 patients in approximately 20 study centres in China. This open label, randomised, parallel group, multicentre study in Chinese pre menopausal patients with ER+/HER2- early breast cancer will be conducted to determine whether 3 monthly ZOLADEX 10.8 mg injection is non-inferior to monthly ZOLADEX 3.6 mg injection in terms of estradiol (E2) suppression. The study will also assess the PK, pharmacodynamics (PD), safety and tolerability of two difference strengths of ZOLADEX. Eligible patients, as judged by the Investigator after completion of the screening tests, will be registered for this study and at the same time randomised in a 1:1 ratio to receive one of the following treatments. The study treatment must start within 7 days after randomisation. • ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks • ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks The primary objective: - To examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24. The secondary objectives: - To evaluate the safety and tolerability profiles of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot. - To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration during the 24 weeks of treatment. - To evaluate the goserelin pharmacokinetics (PK) in Chinese patients after injection of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot. - To assess the influence on menstruous condition after injection of ZOLADEX 10.8 mg depot or ZOLADEX 3.6 mg depot. - To assess the hormonal conditions after injection of ZOLADEX 10.8 mg depot compared with ZOLADEX 3.6 mg depot.
Location
Location
Beijing, China, 100006
Location
Guangzhou, China, 510060
Location
Chengdu, China, 610041
Location
Hangzhou, China, 310022
Location
Hangzhou, China, 310009
Location
Guangzhou, China, 510100
Location
Shijiazhuang, China, 050035
Location
Harbin, China, 150081
Arms | Assigned Interventions |
---|---|
Experimental: ZOLADEX 10.8 mg depot group • ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks | Drug: ZOLADEX 10.8 mg 10.8 mg depot for injection (equivalent to 10.8 mg goserelin) Other Name: ZOLADEX® (goserelin acetate implant) 10.8 mg |
Active Comparator: ZOLADEX 3.6 mg depot group • ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks | Drug: ZOLADEX 3.6mg 3.6 mg depot for injection (equivalent to 3.6 mg goserelin) Other Name: ZOLADEX® (goserelin acetate implant) 3.6 mg |
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