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Selective estrogen receptor downregulators (SERDs) in advanced breast cancer (metastatic) for all type of patients, 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 anastrozole
GEICAM/2006-10, 3000
NCT00543127
500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral anastrozol per day during 5 years
versus
Anastrozol 1 mg daily for 5 yeras
Postmenopausal women with hormone receptor positive and negative Her2 tumoursopen label
spain
FACT (Bergh), 2012
NCT00256698
fulvestrant 500 mg intramuscular on day 1 and 250mgon days 15 and 29 and thereafter every fourth week3 days, until proven progression or undue toxicity, in combination with anastrozole 1 mg orally per day
versus
anastrozole orally at 1 mg per day until proven progression or undue toxicity
first-line therapy for patients with receptor-positive postmenopausal breast cancer opan-label
canada
Mehta(SWOG-S0226), 2012
NCT00075764
Fulvestrant was administered intramuscularly at a dose of 500 mg on day 1 and 250 mg on days 14 and 28 and monthly thereafter.
versus
1 mg of anastrozole orally every day (group 1), with crossover to fulvestrant alone strongly encouraged if the disease progressed,
Postmenopausal women with previously untreated with hormone-receptor (HR)-positive
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 250mg versus anastrozole
Xu et al., 2011
NCT00327769
fulvestrant 250 mg/month
versus
1 mg/day anastrozole
receptor positive postmenopausal advanced breast cancer.double-blind
china
0021 (Osborne), 2002
NCT00635713
intramuscular injection of fulvestrant 250 mg once monthly
versus
daily oral dose of anastrozole 1 mg
postmenopausal women with advanced breast cancerdouble-blind
0020 (Howell), 2002
fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection
versus
oral dose of anastrozole 1 mg
open-label
fulvestrant 250mg versus exemestane
EFECT (Chia), 0
NCT00065325
Fulvestrant 500 mg (2 x 5 mL, im injections) administered as a loading dose on Day 0, followed by 250 mg (1 x 5 mL) on Day 14, Day 28 and monthly (ie, 28 ± 3 days) thereafter.
versus
Exemestane 25 mg administered once daily by mouth (po) from Day 0.
hormone receptor positive postmenopausal women with advanced breast cancerdouble-blind
fulvestrant 250mg versus tamoxifen
9238IL/0025, 0
NCT00241449
intramuscular injection 250 mg
versus
first-line treatment for postmenopausal women with advanced breast cancer.double-blind
USA
0025 (Howell), 2004
fulvestrant 250 mg, via intramuscular injection, once monthly;
versus
tamoxifen 20 mg, orally, once daily
advanced breast cancer in postmenopausal women previously untreated with endocrine therapydouble-blind
fulvestrant 500mg versus anastrozole
FIRST (Robertson), 2010
NCT00274469
500 mg intramuscular injection
versus
anastrozole 1 mg oral tablet
First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
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 1 (Ohno), 2010
28-day cycles of fulvestrant
versus
postmenopausal Japanese women with advanced breast cancer
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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