| Trial | Treatments | Patients | Method |
|---|
| EFECT (Chia) | 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) | hormone receptor positive postmenopausal women with advanced breast cancer | double-blind Sample size: -9/-9 Primary endpoint: Time to disease progression FU duration: |
| D6997L00021 | 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) | Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment | double-blind Sample size: -9/-9 Primary endpoint: FU duration: |
| 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) (n=-9) vs. fulvestrant 250 mg every 28 days (n=-9) | women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment | double-blind Sample size: -9/-9 Primary endpoint: Time to Progression FU duration: |
| Xu et al., 2011 | fulvestrant 250 mg/month (n=121) vs. 1 mg/day anastrozole (n=113) | receptor positive postmenopausal advanced breast cancer. | double-blind Sample size: 121/113 Primary endpoint: Time to Disease Progression FU duration: |
| 0021 (Osborne), 2002 | intramuscular injection of fulvestrant 250 mg once monthly (n=-9) vs. daily oral dose of anastrozole 1 mg (n=-9) | postmenopausal women with advanced breast cancer | double-blind Sample size: -9/-9 Primary endpoint: time to tumor progression FU duration: |
| 9238IL/0025 | intramuscular injection 250 mg (n=-9) vs. (n=-9) | first-line treatment for postmenopausal women with advanced breast cancer. | double-blind Sample size: -9/-9 Primary endpoint: Time to disease progression FU duration: |
| GEICAM/2006-10 | 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) | Postmenopausal women with hormone receptor positive and negative Her2 tumours | open label Sample size: -9/-9 Primary endpoint: free disease survival FU duration: |
| 9238UK/0005 (combination) | (n=-9) vs. (n=-9) 3 arms: fulvestrant and anastrozole, fulvestrant and placebo, and exemestane alone | postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs | double-blind Sample size: -9/-9 Primary endpoint: Progression-free survival FU duration: |
| 0020 (Howell), 2002 | 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: |
| FINDER 1 (Ohno), 2010 | 28-day cycles of fulvestrant (n=-9) vs. (n=-9) | postmenopausal Japanese women with advanced breast cancer | Sample size: -9/-9 Primary endpoint: objective response rate (ORR) FU duration: |
| FINDER 2, 2010 | 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) | Western postmenopausal women recurring or progressing after prior endocrine therapy | Sample size: -9/-9 Primary endpoint: objective response rate (ORR) FU duration: |
| 0025 (Howell), 2004 | fulvestrant 250 mg, via intramuscular injection, once monthly; (n=313) vs. tamoxifen 20 mg, orally, once daily (n=274) | advanced breast cancer in postmenopausal women previously untreated with endocrine therapy | double-blind Sample size: 313/274 Primary endpoint: FU duration: |
| FIRST (Robertson), 2010 | 500 mg intramuscular injection (n=-9) vs. anastrozole
1 mg oral tablet (n=-9) | First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer | Sample size: -9/-9 Primary endpoint: FU duration: |
| SoFEa (Johnston) combination, 2012 | Fulvestrant With Concomitant Anastrozole (n=-9) vs. Exemestane (n=-9) 3 arms: fulvestrant and anastrozole, fulvestrant and placebo, exemestane alone | Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors | Sample size: -9/-9 Primary endpoint: FU duration: |
| 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 (n=258) vs. anastrozole orally at 1 mg
per day until proven progression or undue toxicity
(n=256)
| first-line therapy for patients with receptor-positive postmenopausal breast cancer
| opan-label Sample size: 258/256 Primary endpoint: Time to Progression FU duration:
|
| 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. (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) | Postmenopausal women with previously untreated with hormone-receptor (HR)-positive | Sample size: -9/-9 Primary endpoint: FU duration: |
| 9238UK/0005 (fluvestrant alone) | 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
| postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs
| double-blind Sample size: -9/-9 Primary endpoint: Progression-free survival FU duration:
|
| SoFEa (Johnston) fluvestrant alone, 2012 | 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
| Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
| Parallel groups Sample size: -9/-9 Primary endpoint: FU duration:
|
