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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: ZD9393 (Zoladex) 10.8 mg
* Drug: ZD9393 (Zoladex) 3.6 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: ZD9393 (Zoladex) 10.8 mg<br>* 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).<br>* Other names: Zoladex;|
| Active Comparator: 2<br>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. | Drug: ZD9393 (Zoladex) 3.6 mg<br>* 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).<br>* Other names: Zoladex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Progression-free Survival (PFS) at 24 Weeks | 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. | 24 weeks after the first dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responders at 24 Weeks | 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. | 24 weeks after the first dosing | 
| Oestradiol (E2) Serum Concentrations at 24 Weeks | E2 serum concentrations (pg/mL) at 24 weeks | 24 weeks after the first dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progression Free Survival, ZOLADEX, Pre-menopausal, Oestrogen Receptor, Advanced Breast Cancer