NCT02657343

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research study is a Phase Ib/II clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. Ribociclib is a drug that is designed to block certain proteins called Cyclin-Dependent Kinases (CDKs) that are required for cells to divide. These proteins may also control the ability of certain cancers to grow. In this research study, there will be 3 separate cohorts that are looking for the safe and tolerated dose of ribociclib that can be given in combination with other HER2 directed therapy. One cohort will be looking at the safety of ribociclib in combination with trastuzumab emtansine (T-DM1). T-DM1 is a standard treatment for patients with HER2-positive breast cancer. One Cohort will be looking at the safety of ribociclib in combination with trastuzumab (Herceptin), which is a standard treatment for patients with HER2-positive breast cancer. The last cohort will be looking at the safety of ribociclib in combination with trastuzumab (Herceptin) and fulvestrant (Faslodex) for ER-positive and HER2-positive breast cancer. These are both standard treatments for this type of breast cancer. The FDA (the U.S. Food and Drug Administration) has not approved Ribociclib as a treatment for any disease.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib
DRUG	T-DM1
DRUG	Trastuzumab
DRUG	Fulvestrant

Timeline

• Start date: 2016-03-09
• Primary completion: 2020-08-27
• Completion: 2022-06-30
• First posted: 2016-01-15
• Last updated: 2022-08-01
• Results posted: 2022-06-03

Locations

2 sites across 1 country: United States