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Status:

COMPLETED

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Lead Sponsor:

Puma Biotechnology, Inc.

Conditions:

Breast Neoplasms

Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.

Detailed Description

Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Eligibility Criteria

Inclusion

  • Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
  • Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
  • Over-expression of HER2
  • Tumor tissue available and adequate for analysis at screening
  • At least one measurable lesion

Exclusion

  • Prior treatment with Herceptin (Arm B only)
  • More than 4 prior cytotoxic chemotherapy regimens
  • Subjects with bone or skin as the only site of measurable disease
  • Inadequate cardiac function
  • Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
  • Active central nervous system metastases
  • Pregnant or breastfeeding women
  • Inability to swallow the HKI-272 capsules

Key Trial Info

Start Date :

August 4 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 30 2018

Estimated Enrollment :

136 Patients enrolled

Trial Details

Trial ID

NCT00300781

Start Date

August 4 2006

End Date

January 30 2018

Last Update

August 14 2018

Active Locations (33)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (33 locations)

1

University of Colorado Hospital

Aurora, Colorado, United States, 80045

2

Midwestern Regional Medical Center

Zion, Illinois, United States, 60099

3

Louisiana State University

Shreveport, Louisiana, United States, 71103

4

The Cancer Center at GBMC

Baltimore, Maryland, United States, 21204