CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
neratinibdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Pathologically confirmed breast cancer, stage IIIB, IIIC, or IV
  • ✓HER2 overexpression documented
  • ✓At least one measurable lesion (excluding bone or skin as only site)
  • ✓Tumor tissue available and adequate for analysis at screening
Key exclusion· 8
  • ✕Arm B: Prior treatment with Herceptin
  • ✕More than 4 prior cytotoxic chemotherapy regimens
  • ✕Bone or skin as the only site of measurable disease
  • ✕Inadequate cardiac function

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00300781
NCT00300781Phase 2Completed
CompareCT.gov

Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

Puma Biotechnology, Inc.·interventional·Posted Mar 9, 2006·Updated Aug 14, 2018

In Brief

A Phase 2 clinical trial evaluating neratinib for Breast Neoplasms and Neoplasms. Completed, enrolled 136 participants across 33 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms, Neoplasms
CountriesBelgium, China, France, India, Mexico, Russia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2006
Enrollment StartAug 4, 2006
Primary CompletionApr 1, 2008
Study CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.3 years ago

Interventions

neratinibdrug