Table 3.

Precision medicine in breast cancer.

Study	Phase	Patients enrolled, (%) breast cancer	Intervention	Major findings
SHIVA	II	741 (20 %)	Molecularly-informed therapy (n = 99) vs. Soc (n = 96)	PFS 2.3 vs. 2.0 mos (HR 0.88, p = 0.41)
SAFIR02-BREAST and SAFIR-PI3K	II	1462 (100 %)	Molecularly-informed therapy (n = 157) vs. SoC (n = 81)	PFS 9.1 vs. 2.8 mos (HR 0.41, p < 0.001)
ROME trial	II	1200 (5 %)	Molecularly-informed therapy based on MTB (n = 200) vs. SoC (n = 200)	ORR 17 % vs 9.5 %, p = 0.026 PFS 22.3 % vs 7.7 % mos (HR 0.64, p < 0.001)
AGATA SOLTI-1301	Real-world data	305 (100 %)	N/A	PIK3CA (34 %), TP53 (22 %), AKT1 mutations more frequent in metastatic tissue.
				PFS≥ 6 months in 46.2 % of patients receiving molecularly-informed therapy

Abbreviations HR, hazard ratio; mos, months; MTB, molecular tumor board; NGS, next-generation sequencing; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; SoC, standard of care; hTMB, high tumor mutational burden.