Overview

This trial is active, not recruiting.

Conditions breast neoplasms, neoplasms
Treatments hki-272 (neratinib)
Phase phase 2
Sponsor Puma Biotechnology, Inc.
Start date August 2006
End date April 2008
Trial size 137 participants
Trial identifier NCT00300781, 3144A1-201, B1891012

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with confirmed HER+ breast cancer with prior trastuzumab treatment.
hki-272 (neratinib)
80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen.
(Experimental)
Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.
hki-272 (neratinib)
80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen.

Primary Outcomes

Measure
16 week progression-free survival (PFS) rate of neratinib in women with Her2+ b.c., either with prior Herceptin or no prior Herceptin therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
time frame: 16 weeks

Secondary Outcomes

Measure
Safety of neratinib through monitoring of data collected at biweekly intervals after first dose of study treatment.
time frame: 2 years (average)
Health outcomes profile using EQ5-D, EORTC BR23 at screening, Day 1 of Month 3, Month 5 and at final visit.
time frame: 2 years (average)
Objective response rate, for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study.
time frame: 2 years (average)
Clinical benefit rate (CR +PR +SD), for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study.
time frame: 2 years (average)
Duration of response for women with prior/no prior Herceptin exposure by independent assessment of tumor scans collected every 8 weeks on study.
time frame: 2 years (average)
Pharmacokinetic HKI-272 plasma concentration and HKI-272 metabolites, collecting samples Day 1 predose, Day 29 predose, 2, 7 and 21-24 hours post dose and Day 1 of Month 3, 4, 5 and 6 pre-dose.
time frame: 6 Months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Puma Biotechnology, Inc..