The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
500 mg intramuscular injection
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Nagoyata, Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
The primary objective of this study is to assess the tolerability of 500mg fulvestrant
Time frame: assessed when all patients have been in the study for 6 months
Pharmacokinetics
Time frame: each visit
Time to progression
Time frame: assessed when all patients have been in the study for 6 months
ORR
Time frame: assessed when all patients have been in the study for 6 months
Clinical benefit rate
Time frame: assessed when all patients have been in the study for 6 months
Time to response
Time frame: assessed when all patients have been in the study for 6 months
duration of response and changes in serum tumour markers
Time frame: assessed when all patients have been in the study for 6 months
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