zifeng-ai/TrialReviewBench huggingface dataset:
Study: Hortobagyi GN, 2018 (MONALEESA-2) (Phase III)
Population: Post-menopausalAI-sensitive
Endocrine status: Sensitive
Experimental arm (n): Ribociclib + Letrozole (334)
Control arm (n): Letrozole + Placebo (334)
Median PFS, experimental arm: 25.3 (23.0-30.3)
Median PFS, control arm: 16 (13.4-18.2)
HR (95% CI): 0.568 (0.457-0.704)
Study: Slamon DJ, 2018 (MONALEESA-3) (Phase III)
Population: Post-menopausalAI-sensitive/resistant
Endocrine status: Mixed
Experimental arm (n): Ribociclib + Fulvestrant (484)
Control arm (n): Fulvestrant + Placebo (242)
Median PFS, experimental arm: 20.5 (18.5-23.5)
Median PFS, control arm: 12.8 (10.9-16.3)
HR (95% CI): 0.593 (0.480-0.732)
Study: Tripathy D, 2018 (MONALEESA-7) (Phase III)
Population: Pre-menopausalAI-sensitive
Endocrine status: Mixed
Experimental arm (n): Ribociclib + Tamoxifene or NSAI (335)
Control arm (n): Placebo + Tamoxifene or NSAI (337)
Median PFS, experimental arm: 23.8 (19.2-NR *)
Median PFS, control arm: 13.3 (11.0-16.4)
HR (95% CI): 0.553 (0.441-0.694)
Study: Sledge GW, 2019 (MONARCH-2) (Phase III)
Population: Pre/Post-menopausalAI-resistant
Endocrine status: Resistant
Experimental arm (n): Abemaciclib + Fulvestrant (446)
Control arm (n): Fulvestrant + Placebo (223)
Median PFS, experimental arm: 16.4 (not reported)
Median PFS, control arm: 9.3 (not reported)
HR (95% CI): 0.553 (0.449-0.681)
Study: Johnston S, 2019 (MONARCH-3) (Phase III)
Population: Pre/Post-menopausalAI-sensitive
Endocrine status: Sensitive
Experimental arm (n): Abemaciclib + NSAI (328)
Control arm (n): Placebo + NSAI (165)
Median PFS, experimental arm: 28.1 (not reported)
Median PFS, control arm: 14.7 (not reported)
HR (95% CI): 0.540 (0.418-0.698)
Study: Finn RS, 2015 (PALOMA-1) (Phase II)
Population: Pre/Post-menopausalAI-sensitive
Endocrine status: Sensitive
Experimental arm (n): Palbociclib + Letrozole (84)
Control arm (n): Letrozole (81)
Median PFS, experimental arm: 20.2 (13.8-27.5)
Median PFS, control arm: 10.2 (5.7-12.6)
HR (95% CI): 0.488 (0.319-0.748)
Study: Rugo HS, 2019 (PALOMA-2) (Phase III)
Population: Pre/Post-menopausalAI-sensitive
Endocrine status: Sensitive
Experimental arm (n): Palbociclib + Letrozole (444)
Control arm (n): Letrozole (222)
Median PFS, experimental arm: 27.6 (22.4-30.3)
Median PFS, control arm: 14.5 (12.3-17-1)
HR (95% CI): 0.563 (0.461-0.687)
Study: Cristofanilli M, 2016 (PALOMA-3) (Phase III)
Population: Pre/Post-menopausalAI-resistant
Endocrine status: Resistant
Experimental arm (n): Palbociclib + Fulvestrant (521)
Control arm (n): Fulvestrant + Placebo (347)
Median PFS, experimental arm: 9.5 (9.2-11.0)
Median PFS, control arm: 4.6 (3.5-5.6)
HR (95% CI): 0.46 (0.36-0.59)