RecruitingPhase 1Phase 2NCT05095207

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

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

42 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — abemaciclib (a cell-cycle inhibitor) and bicalutamide (a hormone blocker) — for women with androgen receptor-positive (AR+), HER2-negative metastatic breast cancer. This targets a specific molecular feature of the cancer to block its growth. **You may be eligible if...** - You are a woman 18 or older with metastatic or locally advanced HER2-negative breast cancer - Your cancer tests positive for the androgen receptor (AR+ on biopsy) - Your cancer is measurable or evaluable on imaging - You are in reasonably good physical health (ECOG 0–2) - Your life expectancy is at least 12 weeks - If you have ER+ or PR+ cancer, you have already received prior hormonal therapies **You may NOT be eligible if...** - Your cancer is HER2-positive - You have significant heart disease or poor organ function - You are pregnant or breastfeeding - You have active brain metastases requiring treatment - You have had prior treatment with a CDK4/6 inhibitor (like palbociclib or ribociclib) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAbemaciclib

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.

DRUGBicalutamide

150 mg orally daily, day 1 to 28.


Locations(3)

Mount Sinai Beth Israel

New York, New York, United States

Mount Sinai - West

New York, New York, United States

Dubin breast Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05095207


Related Trials