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Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer

2019-09-17 02:47:23 | BioPortfolio

Summary

The purpose of this study is to test the efficacy, safety and tolerability of a combination of immunotherapy and anticancer drugs presurgery in patients with hormone-receptor positive breast cancer.

Description

The primary hypothesis is that a Programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor combined with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor will be well tolerated in early stage, hormone receptor positive (HR+) breast cancer patients treated with neoadjuvant endocrine therapy (NET). The secondary hypothesis and biomarker based endpoint is that patients with HR positive locally advanced breast cancer with low to intermediate stromal tumor-infiltrating lymphocytes (TILs) will demonstrate an increase in stromal TILs following NET when combined with abemaciclib and durvalumab for 4 cycles (16 weeks).

Study Design

Conditions

Breast Cancer Female

Intervention

Abemaciclib, durvalumab and aromatase inhibitor

Location

Stony Brook University Cancer Center
Stony Brook
New York
United States
11794

Status

Not yet recruiting

Source

Stony Brook University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-17T02:47:23-0400

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