OncRef

Clinical Trial: NCT01494662

HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Dana-Farber Cancer Institute
Information Provided By:Dana-Farber Cancer Institute
Last Update Posted:2026-01-23

Study Overview

Brief Summary

The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).

In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.

Official Title

A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: HKI-272
  • Procedure: Surgical Resection
  • Drug: Capecitabine
  • Drug: HKI-272
  • Drug: Ado-Trastuzumab Emtansine

Other Study ID Numbers

  • 11-344
  • TBCRC 022

Start Date (Actual)

2012-02

Primary Completion Date (Actual)

2023-02-01

Study Completion Date (Actual)

2024-04-19

Enrollment (Actual)

140

Study Type

Interventional

Phase

Phase 2