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

NCT01494662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-23

Study results available
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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.

Conditions

Interventions

DRUG

HKI-272

240 mg orally, once daily

PROCEDURE

Surgical Resection

Neratinib concentrations from craniotomy specimen, CSF, plasma Neratinib.

DRUG

Capecitabine

750 mg/m2 orally, twice daily (1,500 mg/m2 daily) for 14 days followed by 7 days off

DRUG

HKI-272

160 mg orally, once daily

DRUG

Ado-Trastuzumab Emtansine

3.6 mg/kg IV every 3 weeks

Sponsors & Collaborators

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Rachel Freedman, M.D., M.P.H. · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2023-02-01
Completion
2024-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494662 on ClinicalTrials.gov