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
Overview
- Phase
- Phase 2
- Intervention
- Neratinib
- Conditions
- Advanced Breast Cancer
- Sponsor
- Puma Biotechnology, Inc.
- Enrollment
- 233
- Locations
- 152
- Primary Endpoint
- Progression Free Survival
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Neratinib
Intervention: Neratinib
Lapatinib plus Capecitabine
Intervention: Lapatinib
Lapatinib plus Capecitabine
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: From randomization date to progression or death, assessed up to 69 months
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Secondary Outcomes
- Overall Survival (OS)(From randomization date to death, assessed up to 69 months)
- Clinical Benefit Rate(From randomization date to progression or last tumor assessment, assessed up to 69 months)
- Objective Response Rate (ORR).(From randomization date to progression or last tumor assessment, assessed up to 69 months)
- Duration of Response(From start date of response to first PD, assessed up to 69 months after the first subject was randomized.)
- Time to CNS Metastases(From randomization date to first CNS symptom or lesions)
- Frequency of CNS Metastases (Frequency)(From randomization date to first CNS symptom or lesions)