Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Phase 3 Active not recruiting 1684 enrolled West German Study Group Genomic Health®, Inc. · collab Novartis · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

Timeline

Start: 2019-07-02
Primary completion: 2027-07-31
Completion: 2027-07-31

Publications

Klier K, Patel YJ, Schinkothe T, Harbeck N, Schmidt A. Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study. JMIR Cardio. 2023 Sep 11;7:e48096. doi: 10.2196/48096.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribociclib	Small molecule	200 mg	Oral

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Summary

Timeline

Publications

Drugs

Indications