Phase 2
Completed N=233
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00777101 ↗Enrolled (actual)
233
Serious AEs
23.8%
Results posted
Nov 2017
Primary outcomePrimary: Progression Free Survival — 4.53; 6.83 months — p=0.231
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
4.53; 6.83 | 0.231 |
| SECONDARY Overall Survival (OS) |
19.74; 23.62 | — |
| SECONDARY Objective Response Rate (ORR). |
29.1; 40.5 | — |
| SECONDARY Clinical Benefit Rate |
44.4; 63.8 | — |
| SECONDARY Duration of Response |
12.48; 7.98 | — |
| SECONDARY Frequency of CNS Metastases (Frequency) |
9.4; 12.9 | — |
| SECONDARY Time to CNS Metastases |
19.68; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT00777101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.