Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: ZD9393 (Zoladex) 10.8 mg; Drug: ZD9393 (Zoladex) 3.6 mg

• Registration Number: NCT01073865
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Study Start: 2010-02-26
• Primary Completion: 2012-09-19
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-12-09
• Results First Posted: 2014-01-10
• Study Completion: 2017-11-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 222

Inclusion Criteria

• Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation.
• Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
• Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

Exclusion Criteria

• Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
• Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
• Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ZD9393 (Zoladex) 10.8 mg	Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days). One oral tamoxifen 20 mg tablet also will be taken daily
2	ZD9393 (Zoladex) 3.6 mg	Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Progression-free Survival (PFS) at 24 Weeks	24 weeks after the first dosing	A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.

Secondary Outcome Measures

Name	Time	Method
Oestradiol (E2) Serum Concentrations at 24 Weeks	24 weeks after the first dosing	E2 serum concentrations (pg/mL) at 24 weeks
Number of Responders at 24 Weeks	24 weeks after the first dosing	Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.

Trial Locations

Locations (1)

Research Site; 🇹🇭 Ubonratchathani, Thailand