Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Breast CancerMetastasis
Interventions
DRUG

Abemaciclib

100 mg orally twice daily, day 1 to 28. If no toxicity in cycle 1 for the first 3 patients, increase dose to 150mg orally twice daily day 1-28 and enroll 3 patients. If excessive toxicity experienced at 100mg orally twice daily dose, decrease dose to 50mg orally twice daily day 1-28.

DRUG

Bicalutamide

150 mg orally daily, day 1 to 28.

Trial Locations (3)

10003

RECRUITING

Mount Sinai Beth Israel, New York

10019

RECRUITING

Mount Sinai - West, New York

10029

RECRUITING

Dubin breast Center, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER