This trial is active, not recruiting.

Conditions advanced breast cancer, breast cancer
Treatments neratinib, lapatinib, capecitabine
Phase phase 2
Sponsor Puma Biotechnology, Inc.
Start date February 2009
End date March 2011
Trial size 233 participants
Trial identifier NCT00777101, 3144A2-3003, B1891003


This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

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
neratinib HKI-272
Tablets, 240mg once per day until disease progression or unacceptable toxicity
(Active Comparator)
Lapatinib plus Capecitabine
lapatinib Tykerb, Tyverb
Tablets 1250mg once per day until disease progression or unacceptable toxicity.
capecitabine Xeloda
Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Primary Outcomes

Progression Free Survival
time frame: 16 Weeks

Secondary Outcomes

Common Terminology Criteria for Adverse Events [CTCAE] V3
time frame: Subject's duration on active portion of the study.
Clinical benefit rate, objective response rate, duration of response
time frame: subject's duration
Frequency of and time to central nervous system metastases
time frame: subject's duration
Population PK
time frame: 22 days

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer - Prior use of Herceptin (trastuzumab), and a taxane - Adequate cardiac and renal function Exclusion Criteria: - More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb] - Bone as the only site of disease - Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids) - Significant gastrointestinal disorder with diarrhea as major symptom

Additional Information

Official title A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Puma Biotechnology, Inc..