Fulvestrant Selective estrogen receptor downregulators (SERDs)

Description Results NMA

time to progression (TTP) 0.96 [0.82; 1.13]

time to progression (TTP) 0.92 [0.74; 1.14]

time to progression (TTP) 0.98 [0.79; 1.21]

time to progression (TTP) 1.18 [0.97; 1.44]

time to progression (TTP) 0.66 [0.47; 0.92]

PFS 0.95 [0.79; 1.14]

time to progression (TTP) 0.95 [0.79; 1.14]

OS 1.00 [0.76; 1.32]

PFS 0.99 [0.81; 1.20]

RR 0.92 [0.54; 1.57]

time to progression (TTP) 0.99 [0.82; 1.20]

PFS 0.80 [0.68; 0.94]

time to progression (TTP) 0.80 [0.68; 0.94]

OS 0.81 [0.65; 1.00]

RR 1.33 [0.83; 2.14]

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. (n=-9)

vs.

Exemestane 25 mg administered once daily by mouth (po) from Day 0. (n=-9)

double-blind

Sample size: -9/-9

Primary endpoint: Time to disease progression

FU duration:

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 (n=-9)

vs.

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 (n=-9)

double-blind

Sample size: -9/-9

Primary endpoint:

FU duration:

fulvestrant 500 mg (500 mg intramuscularly [IM] on day 0, then 500 mg IM on days 14 and 28 and every 28 days thereafter) (n=-9)

vs.

fulvestrant 250 mg every 28 days (n=-9)

double-blind

Sample size: -9/-9

Primary endpoint: Time to Progression

FU duration:

fulvestrant 250 mg/month (n=121)

vs.

1 mg/day anastrozole (n=113)

double-blind

Sample size: 121/113

Primary endpoint: Time to Disease Progression

FU duration:

intramuscular injection of fulvestrant 250 mg once monthly (n=-9)

vs.

daily oral dose of anastrozole 1 mg (n=-9)

double-blind

Sample size: -9/-9

Primary endpoint: time to tumor progression

FU duration:

intramuscular injection 250 mg (n=-9)

vs.

(n=-9)

double-blind

Sample size: -9/-9

Primary endpoint: Time to disease progression

FU duration:

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 (n=-9)

vs.

Anastrozol 1 mg daily for 5 yeras (n=-9)

open label

Sample size: -9/-9

Primary endpoint: free disease survival

FU duration:

(n=-9)

vs.

(n=-9)

3 arms: fulvestrant and anastrozole, fulvestrant and placebo, and exemestane alone

double-blind

Sample size: -9/-9

Primary endpoint: Progression-free survival

FU duration:

fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection (n=-9)

vs.

oral dose of anastrozole 1 mg (n=-9)

open-label

Sample size: -9/-9

Primary endpoint: time to progression

FU duration:

28-day cycles of fulvestrant (n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint: objective response rate (ORR)

FU duration:

500 mg (high dose [HD]; 500 mg/month plus 500 mg on day 14 of Month 1). (n=-9)

vs.

fulvestrant: 250 mg/month (approved dose [AD]); (n=-9)

Sample size: -9/-9

Primary endpoint: objective response rate (ORR)

FU duration:

fulvestrant 250 mg, via intramuscular injection, once monthly; (n=313)

vs.

tamoxifen 20 mg, orally, once daily (n=274)

double-blind

Sample size: 313/274

Primary endpoint:

FU duration:

500 mg intramuscular injection (n=-9)

vs.

anastrozole 1 mg oral tablet (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

Fulvestrant With Concomitant Anastrozole (n=-9)

vs.

Exemestane (n=-9)

3 arms: fulvestrant and anastrozole, fulvestrant and placebo, exemestane alone

Sample size: -9/-9

Primary endpoint:

FU duration:

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 (n=258)

vs.

anastrozole orally at 1 mg per day until proven progression or undue toxicity (n=256)

opan-label

Sample size: 258/256

Primary endpoint: Time to Progression

FU duration:

Fulvestrant was administered intramuscularly at a dose of 500 mg on day 1 and 250 mg on days 14 and 28 and monthly thereafter. (n=-9)

vs.

1 mg of anastrozole orally every day (group 1), with crossover to fulvestrant alone strongly encouraged if the disease progressed, (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression (n=-9)

vs.

exemestane oral, once daily until disease progression. (n=-9)

3 arms: fulvestrant and anastrozole, fulvestrant and placebo, and exemestane alone

double-blind

Sample size: -9/-9

Primary endpoint: Progression-free survival

FU duration:

fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly (n=-9)

vs.

exemestane once daily (n=-9)

3 arms: fulvestrant and anastrozole, fulvestrant and placebo, exemestane alone

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: