Table 3.

Ongoing clinical trials in premenopausal patients with hormone receptor–positive/human epidermal growth receptor 2–negative mBC

Identifier (name)	Phase	Target enrollment	Treatment arm(s)	Outcome measures
NCT03096847	3b	504	Ribociclib + letrozole + goserelin	Primary: CBR Secondary: PFS, OS, QoL
NCT03839823 (RIGHT Choice)	2	222	Experimental: ribociclib + letrozole/anastrozole + goserelin Control: combination chemotherapy	Primary: PFS Secondary: TTF, ORR, CBR, OS, AEs, QoL
NCT02384239	2	70	Palbociclib (100 or 125 mg) + fulvestrant or tamoxifen	Primary: Tumor progression (RECIST v1.1) Secondary: PFS, CBR, biomarkers
NCT02917005 (FATIMA)	2	160	Experimental: palbociclib + exemestane + goserelin Control: exemestane + goserelin	Primary: PFS Secondary: ORR, CBR, OS, TRAEs
NCT02592746 (KCSG BR 15‐10; Young‐PEARL)	2	182	Experimental: palbociclib + exemestane + goserelin Control: capecitabine	Primary: PFS
NCT03481998	1/2	146	SHR6390 + letrozole, anastrozole, or fulvestrant	Primary: AEs Secondary: PK/PD, ORR, PFS, DCR
NCT02990845 (PEER)	1/2	25	Pembrolizumab + exemestane + leuprolide	Primary: PFS Secondary: TRAEs, ORR, CBR, DOR

Abbreviations: AE, adverse event; CBR, clinical benefit rate; DCR, disease control rate; DOR, duration of response; mBC, metastatic breast cancer; ORR, overall response rate; OS, overall survival; PD, pharmacodynamics; PFS, progression‐free survival; PK, pharmacokinetics; QoL, quality of life; TRAE, treatment‐related adverse event; TTF, time to treatment failure.