| Fulvestrant | advanced breast cancer (metastatic), in all type of patients | vs anastrozole | progression (Time to progression TTP) by 12% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.88 [0.81 0.97] | p=0.04 | 0 | 442 | 5 | 0021 (Osborne), 0020 (Howell), FIRST (Robertson), FACT (Bergh), Mehta(SWOG-S0226), | | objective response (ORR) | 1.13 [0.79 1.61] | p=1.00 | 0 | 496 | 2 | FACT (Bergh), Mehta(SWOG-S0226), | | death (overall survival) | 0.88 [0.74 1.04] | p=1.00 | 0 | 496 | 2 | FACT (Bergh), Mehta(SWOG-S0226), | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| Xu et al., 2011 | fulvestrant 250 mg/month | 1 mg/day anastrozole | receptor positive postmenopausal advanced breast cancer. | | 0021 (Osborne), 2002 | intramuscular injection of fulvestrant 250 mg once monthly | daily oral dose of anastrozole 1 mg | postmenopausal women with advanced breast cancer | | GEICAM/2006-10, 3000 | 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 | Anastrozol 1 mg daily for 5 yeras | Postmenopausal women with hormone receptor positive and negative Her2 tumours | | 0020 (Howell), 2002 | fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection | oral dose of anastrozole 1 mg | | | FIRST (Robertson), 2010 | 500 mg intramuscular injection | anastrozole
1 mg oral tablet | First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer | | FACT (Bergh), 2012 | 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 | anastrozole orally at 1 mg
per day until proven progression or undue toxicity
| first-line therapy for patients with receptor-positive postmenopausal breast cancer
| | Mehta(SWOG-S0226), 2012 | Fulvestrant
was administered intramuscularly at a dose of 500 mg on day 1 and 250 mg
on days 14 and 28 and monthly thereafter. | 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 | | vs exemestane | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.95 [0.79 1.14] | p=1.00 | 0 | -18 | 1 | SoFEa (Johnston) combination, | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| EFECT (Chia), 0 | 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. | Exemestane 25 mg administered once daily by mouth (po) from Day 0. | hormone receptor positive postmenopausal women with advanced breast cancer | | 9238UK/0005 (combination), 0 | | | postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs | | SoFEa (Johnston) combination, 2012 | Fulvestrant With Concomitant Anastrozole | Exemestane | Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors | | 9238UK/0005 (fluvestrant alone), 0 | fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression
| exemestane oral, once daily until disease progression.
| postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs
| | SoFEa (Johnston) fluvestrant alone, 2012 | fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly | exemestane once daily | Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
|
| |
| Fulvestrant | | vs fulvestrant 250mg | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| D6997L00021, 3000 | 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 | 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 treatment | | CONFIRM (Di Leo), 2010 | fulvestrant 500 mg
(500 mg intramuscularly [IM] on day 0, then 500 mg IM on days 14 and 28 and every 28 days
thereafter) | fulvestrant 250 mg every 28 days | women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment | | FINDER 1 (Ohno), 2010 | 28-day cycles of fulvestrant | | postmenopausal Japanese women with advanced breast cancer | | FINDER 2, 2010 | 500 mg (high dose [HD]; 500 mg/month plus 500 mg on day 14 of Month 1). | fulvestrant: 250 mg/month (approved dose [AD]); | Western postmenopausal women recurring or progressing after prior endocrine therapy |
| |
| Fulvestrant | | vs tamoxifen | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 1.18 [0.97 1.44] | p=1.00 | 0 | 587 | 1 | 0025 (Howell), | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| 9238IL/0025, 0 | intramuscular injection 250 mg | | first-line treatment for postmenopausal women with advanced breast cancer. | | 0025 (Howell), 2004 | fulvestrant 250 mg, via intramuscular injection, once monthly; | tamoxifen 20 mg, orally, once daily | advanced breast cancer in postmenopausal women previously untreated with endocrine therapy |
| |
| Fulvestrant | advanced breast cancer (metastatic), in patients recurring or progressing after prior endocrine therapy | vs exemestane | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.95 [0.79 1.14] | p=1.00 | 0 | -18 | 1 | SoFEa (Johnston) combination, | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| 9238UK/0005 (combination), 0 | | | postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs | | SoFEa (Johnston) combination, 2012 | Fulvestrant With Concomitant Anastrozole | Exemestane | Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors | | 9238UK/0005 (fluvestrant alone), 0 | fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression
| exemestane oral, once daily until disease progression.
| postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs
| | SoFEa (Johnston) fluvestrant alone, 2012 | fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly | exemestane once daily | Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
|
| |
| Fulvestrant | | vs fulvestrant 250mg | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| D6997L00021, 3000 | 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 | 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 treatment | | CONFIRM (Di Leo), 2010 | fulvestrant 500 mg
(500 mg intramuscularly [IM] on day 0, then 500 mg IM on days 14 and 28 and every 28 days
thereafter) | fulvestrant 250 mg every 28 days | women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment | | FINDER 2, 2010 | 500 mg (high dose [HD]; 500 mg/month plus 500 mg on day 14 of Month 1). | fulvestrant: 250 mg/month (approved dose [AD]); | Western postmenopausal women recurring or progressing after prior endocrine therapy |
| |
| Fulvestrant | advanced breast cancer (metastatic), in first line endocrine therapy | vs anastrozole | progression (Time to progression TTP) by 15% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.85 [0.75 0.95] | p=0.04 | 0 | 478 | 3 | FIRST (Robertson), FACT (Bergh), Mehta(SWOG-S0226), | | objective response (ORR) | 1.13 [0.79 1.61] | p=1.00 | 0 | 496 | 2 | FACT (Bergh), Mehta(SWOG-S0226), | | death (overall survival) | 0.88 [0.74 1.04] | p=1.00 | 0 | 496 | 2 | FACT (Bergh), Mehta(SWOG-S0226), | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| FIRST (Robertson), 2010 | 500 mg intramuscular injection | anastrozole
1 mg oral tablet | First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer | | FACT (Bergh), 2012 | 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 | anastrozole orally at 1 mg
per day until proven progression or undue toxicity
| first-line therapy for patients with receptor-positive postmenopausal breast cancer
| | Mehta(SWOG-S0226), 2012 | Fulvestrant
was administered intramuscularly at a dose of 500 mg on day 1 and 250 mg
on days 14 and 28 and monthly thereafter. | 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 | | vs tamoxifen | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 1.18 [0.97 1.44] | p=1.00 | 0 | 587 | 1 | 0025 (Howell), | | objective response (ORR) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| 9238IL/0025, 0 | intramuscular injection 250 mg | | first-line treatment for postmenopausal women with advanced breast cancer. | | 0025 (Howell), 2004 | fulvestrant 250 mg, via intramuscular injection, once monthly; | tamoxifen 20 mg, orally, once daily | advanced breast cancer in postmenopausal women previously untreated with endocrine therapy |
| |
