Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments neratinib, trastuzumab, paclitaxel
Phase phase 2
Sponsor Puma Biotechnology, Inc.
Start date August 2009
End date August 2013
Trial size 480 participants
Trial identifier NCT00915018, 3144A2-3005, B1891005

Summary

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
neratinib
Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
paclitaxel Taxol
Paclitaxel - 80mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
(Active Comparator)
trastuzumab Herceptin
Trastuzumab - 4mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
paclitaxel Taxol
Paclitaxel - 80mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Primary Outcomes

Measure
Progression-Free Survival
time frame: 31 months

Secondary Outcomes

Measure
Overall Survival
time frame: 43 months
Objective Response Rate
time frame: 31 months
Duration of Response
time frame: 31 months
Clinical Benefit Rate
time frame: 31 months
Incidence of Adverse Events between treatment arms
time frame: 31 months
Patient Reported Breast Specific Quality of Life
time frame: 31 months
Frequency of symptomatic or progressive CNS lesions
time frame: 31 months
Time to symptomatic or progressive CNS lesions
time frame: 31 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - ErbB-2 positive locally recurrent or metastatic breast cancer - Eastern Cooperative Oncology Group (ECOG) 0-2 - Measurable disease - Availability of tumor tissue for HER2 status confirmation Exclusion Criteria: - Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease - Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting - Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy - history of heart disease - history of gastrointestinal disease

Additional Information

Official title A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Puma Biotechnology, Inc..