Phase 3
Completed N=621
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
HER2+ Metastatic Breast Cancer (MBC)
Source: ClinicalTrials.gov NCT01808573 ↗
Enrolled (actual)
621
Serious AEs
31.9%
Results posted
Dec 2019
Primary outcomePrimary: Centrally Assessed Progression Free Survival — 8.8; 6.6 months — p=0.0059
◆ Published Evidence
Highly cited
608citations · ~101 / year
Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.
Summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Linked Publications (2)
-
Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.
-
Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Centrally Assessed Progression Free Survival |
8.8; 6.6 | 0.0059 sig |
| PRIMARY Overall Survival |
24.0; 22.2 | 0.2086 |
| SECONDARY Intervention for Symptomatic Metastatic Central Nervous System Disease |
22.76; 29.19 | 0.043 sig |
| SECONDARY Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening) |
32.8; 26.7 | 0.1201 |
| SECONDARY Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening) |
44.5; 35.6 | 0.0328 sig |
| SECONDARY Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening) |
8.54; 5.55 | 0.0004 sig |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) |
99.7; 99.4; 34.0; 29.9 | — |
Eligibility Criteria
Inclusion Criteria
- Aged ≥18 years at signing of informed consent.
- Histologically confirmed MBC, current stage IV.
- Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Exclusion Criteria
- Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Data sourced from ClinicalTrials.gov (NCT01808573) and the linked publication. 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.