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Trial · NCT01958021

NCT01958021

2016
New England Journal of Medicine
Sponsor: Novartis Pharmaceuticals

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

Gabriel N. Hortobagyi et al. · PI Novartis Pharmaceuticals

Primary endpoint

Progression Free Survival (PFS) by Investigator Assessment

Population

Advanced, Metastatic Breast Cancer; n=668

doi:10.1056/NEJMoa1609709
Historical

1

Current

1

Future

1

3 noemes

Historical

1 noeme

Published findings from this trial. Vote whether the expert body still believes each noeme stands given current evidence.

The MONALEESA-2 trial's stated primary conclusion — Adding ribociclib to letrozole improves progression-free survival in HR+/HER2− advanced breast cancer. — replicates in independent cohorts.

oncology
Current

1 noeme

Noemes tracking active replication, subgroup analysis, or long-term follow-up. Vote on the likelihood the original effect holds.

Recent follow-up analyses of MONALEESA-2 are confirming the original effect size in real-world data.

oncology
Future

1 noeme

Open forecast horizons tied to this trial. Vote your probability that each resolves TRUE by the declared horizon.

By 2028, CDK4/6 inhibitors will remain standard first-line for HR+/HER2− metastatic breast cancer; resistance-overcoming agents (e.g., AKT/PI3K) will be layered on top.

oncology

P

71%