NCT03090165

Ribociclib and Bicalutamide in AR+ TNBC

A Phase I/II, Single Arm, Non-randomized Study of Ribociclib (LEE011), a CDK 4/6 Inhibitor, in Combination With Bicalutamide, an Androgen Receptor (AR) Inhibitor, in Advanced AR+ Triple-negative Breast Cancer: Big Ten Cancer Research Consortium BRE15-024

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Kari Wisinski · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.

Detailed description

This is a non-randomized, single arm, open label study of the combination of bicalutamide with ribociclib in subjects with advanced AR+ TNBC. Prior to enrollment on the phase II cohort, a phase I run-in study will be performed to ensure safety and tolerability of the combination of bicalutamide and ribociclib in subjects with advanced AR+ TNBC. In both the phase I and phase II portions of the study, subjects will receive bicalutamide 150 mg orally, once daily, continuously on Day 1 to Day 28. Each cycle of treatment is 28 days. In the phase I portion of the study, cohorts of subjects will receive ribociclib in escalated doses orally, once daily in a 28 day cycle. For the phase II portion, the RP2D dose of ribociclib will be based on the phase I run-in. In the phase II cohort, a two week lead-in of bicalutamide monotherapy will occur before cycle 1 combination therapy (Day -14 to day -1). Then ribociclib will be added on day 1 of cycle 1. This lead-in will be for CTC androgen receptor analysis.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	ribociclib	400mg PO
DRUG	ribociclib	600mg PO
DRUG	Bicalutamide	150mg PO

Timeline

• Start date: 2018-05-07
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2017-03-24
• Last updated: 2026-01-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study