Table 1.
List of phase II/III trials using fulvestrant
| Study/Trial name (n) | Treatment regimen | Line of treatment | CBR/ORR (%) | Survival | |
|---|---|---|---|---|---|
| OS, months | PFS, months | ||||
| Fulvestrant as monotherapy | |||||
| FALCON (n = 462)31 | F 500 mg, anastrozole 1 mg | 1st | CBR: 78 vs 74 | NA | 16.6 vs 13.8* |
| FIRST (n = 205)27, 28, 29 | F 500 mg, anastrozole 1 mg | 1st | CBR: 72.5 vs 67.0 | 54.1 vs 48.4* | 23.4 vs 13.1* |
| CONFIRM (n = 736)24, 25 | F 500 mg, F 250 mg | 2nd | CBR: 45.6 vs 39.6 | 26.4 vs 22.3* | 6.5 vs 5.5** |
| Fulvestrant + other endocrine therapy | |||||
| FACT (n = 514)40 | F 250 mg + anastrozole, anastrozole | 1st | NA | 38.2 vs 37.8 | 10.8 vs 10.2 |
| SWOG (n = 694)41 | F 250 mg + anastrozole, anastrozole, fulvestrant | 1st | CBR: 73.0 vs 70.0 | 47.7 vs 41.3* | 15 vs 13.5** |
| SoFEA (n = 723) 43 | F 500/250 mg + anastrozole, F 500 mg + placebo, exemestane | 2nd | NA | 20.2 vs 19.4 | 4.4 vs 4.8 vs 3.4 |
| Fulvestrant + CDK inhibitor | |||||
| PALOMA 3 (n = 521)44, 45 | F 500 mg + palbociclib, F 500 mg + placebo | 2nd | CBR: 24.6 vs 10.9* | NA | 9.5 vs 4.6** |
| MONARCH 2 (n = 669)46 | F 500 mg + abemaciclib vs F 500 mg + placebo | 2nd | ORR: 48.1 vs 21.3 | NA | 16.4 vs 9.3* |
| MONALEESA 3 (n = 726)47 | F 500 mg + ribociclib. F 500 mg + placebo | 2nd | ORR: 32.4 vs 21.5** | NA | 20.5 vs 12.8** |
| Fulvestrant + mTOR inhibitor | |||||
| PrECOG (n = 131)48 | F 500 mg + everolimus, F 500 mg + placebo | 2nd | NA | NA | 10.4 vs 5.1* |
| Fulvestrant + PI3K inhibitor | |||||
| SANDPIPER (n = 516)49 | F 500 mg + taselisib, F 500 mg + placebo | 2nd |
ORR: 28.0 vs 11.9**
CBR: 51.5 vs 37.3 |
NA | 7.4 vs 5.4* |
| BELLE‐2 (n = 1147)50 | F 500 mg + buparlisib, F 500 mg + placebo | 2nd | ORR: 11.8 vs 7.7 | NA | 6.9 vs 5.0** |
| FERGI (n = 168)51 | F 500 mg + pictilisib, F 500 mg + placebo | 2nd | ORR: 7.9 vs 6.3 | NA | 6.6 vs 5.1 |
| BELLE‐3 (n = 432)52 | F 500 mg + buparlisib, F 500 mg, F 500 mg + placebo | 2nd | ORR: 7.6 vs 2.1 | 7.6 vs 2.1 | 3.9 vs 1.8** |
| LEA (n = 380)53 | F 250 mg or letrozole + bevacizumab, F 250 mg or letrozole + placebo | 1st | CBR: 76.8 vs 67.4 | 52.1 vs 51.8 | 19.3 vs 14.4 |
| Fulvestrant + EGFR, HER2 inhibitor | |||||
| CALGB (n = 291)54 | F 500 mg + lapatinib, F 500 mg + placebo | 1st | NA | 30 vs 26.4 | 4.7 vs 3.8 |
| Robertson et.al (n = 156)55 | F 250 mg or exemestane + ganitumab, F 250 mg or exemestane + placebo | 2nd | NA | 22.2 vs NA | 5.7 vs 3.9 |
CDK, cyclin‐dependent kinase; CBR, clinical benefit rate; ORR, overall response rate; EGFR, epidermal growth factor receptor; F, fulvestrant; HER2, human epidermal growth factor receptor type 2; IGFR, insulin‐like growth factor receptor; mTOR, mammalian target of rapamycin; N, number of patients; OS, overall survival; PFS, progression‐free survival; PI3K, phosphoinositide 3‐kinase. Modified from Boer, Ther. Adv. Med. Oncol. 2017;9(7):465‐479.4
*
P < 0.05.
**
P < 0.001.