An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Phase 1/2 Completed 25 enrolled Dana-Farber Cancer Institute Novartis · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment. This research study is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a possible treatment for this diagnosis.

Timeline

Start: 2016-03-09
Primary completion: 2020-08-27
Completion: 2022-06-30

Publications

Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clin Breast Cancer. 2019 Dec;19(6):399-404. doi: 10.1016/j.clbc.2019.05.010. Epub 2019 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulvestrant	Small molecule	—	—
Subject	Ribociclib	Small molecule	300 mg	Oral
Subject	Ribociclib	Small molecule	400 mg	Oral
Subject	Ribociclib	Small molecule	500 mg	Oral
Subject	Ribociclib	Small molecule	600 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Trastuzumab emtansine	Other / unclassified	—	Intravenous

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Summary

Timeline

Publications

Drugs

Indications