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Selective estrogen receptor downregulators (SERDs) in advanced breast cancer (metastatic) for patients recurring or progressing after prior endocrine therapy , clinical trials results

fluvestrant 250mg versus exemestane
9238UK/0005 (fluvestrant alone), 0
NCT00944918
fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression
versus
exemestane oral, once daily until disease progression.
postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs double-blind
Korea
SoFEa (Johnston) fluvestrant alone, 2012
NCT00253422
fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly
versus
exemestane once daily
Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
UK
fulvestrant + anastrozole versus exemestane
9238UK/0005 (combination), 0
NCT00944918

versus
postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIsdouble-blind
Korea
SoFEa (Johnston) combination, 2012
NCT00253422
Fulvestrant With Concomitant Anastrozole
versus
Exemestane
Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
fulvestrant 500mg versus fulvestrant 250mg
D6997L00021, 3000
NCT01300351
Fulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only
versus
Fulvestrant 250mg (1 syringe of fulvestrant 250mg + 1 syringe matching placebo), Fulvestrant 250 mg and matching placebo i.m. every 28 (+/- 3) days plus an additional 2 placebo syringes on day 14 (+/-3) of first month only
Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatmentdouble-blind
China
CONFIRM (Di Leo), 2010
NCT00099437
fulvestrant 500 mg (500 mg intramuscularly [IM] on day 0, then 500 mg IM on days 14 and 28 and every 28 days thereafter)
versus
fulvestrant 250 mg every 28 days
women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatmentdouble-blind
US
FINDER 2, 2010
NCT00313170
500 mg (high dose [HD]; 500 mg/month plus 500 mg on day 14 of Month 1).
versus
fulvestrant: 250 mg/month (approved dose [AD]);
Western postmenopausal women recurring or progressing after prior endocrine therapy

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