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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
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.
Time frame: 24 weeks after the first dosing
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.
Time frame: 24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
E2 serum concentrations (pg/mL) at 24 weeks
Time frame: 24 weeks after the first dosing
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Research Site
Ahmedabad, India
Research Site
Bangalore, India
Research Site
Bangalore, India
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Chennai, India
Research Site
Hubli, India
Research Site
Hyderabad, India
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Jaipur, India
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Mumbai, India
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Nagpur, India
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New Delhi, India
...and 45 more locations