Phase 3
Completed N=2,840
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Source: ClinicalTrials.gov NCT00878709 ↗Enrolled (actual)
2,840
Serious AEs
6.7%
Results posted
Oct 2017
Primary outcomePrimary: Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 — 4.7; 7.5 percentage of participants with events — p=0.008
Summary
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 |
4.7; 7.5 | 0.008 sig |
| PRIMARY Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms |
94.2; 91.9 | — |
| SECONDARY Overall Survival (OS) |
99.64; 99.43; 96.74; 96.44; 94.09; 93.26 | 0.6914 |
| SECONDARY Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 |
4.7; 8.0 | — |
| SECONDARY Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms |
94.2; 91.3 | — |
| SECONDARY Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 |
3.8; 5.4 | — |
| SECONDARY Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms |
95.3; 94.0 | — |
| SECONDARY Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 |
3.7; 5.3 | — |
| SECONDARY Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms |
95.5; 94.2 | — |
| SECONDARY Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 |
0.8; 1.1 | — |
| SECONDARY Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 |
0.92; 1.16 | — |
Eligibility Criteria
Inclusion Criteria
- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
- Been treated for early breast cancer with standard of care duration of trastuzumab.
- Could have been treated neoadjuvantly but have not reached pathologic complete response.
Exclusion Criteria
- Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
- History of heart disease.
- Corrected QT (QTc) interval >0.45 seconds
- History of gastrointestinal disease with diarrhea as the major symptom.
Data sourced from ClinicalTrials.gov (NCT00878709). 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.