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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

NCT01808573 · NALA Phase 3Completed

Lead sponsor
Puma Biotechnology, Inc. (Industry)
Enrollment
621 (actual)
Start date
29 Mar 2013
Primary completion
28 Sep 2018 (actual)
Study completion
9 Dec 2019
Last update posted
11 Jun 2021

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • neratinib Drug
  • capecitabine Drug
  • lapatinib Drug

Conditions and primary outcome

  • HER2+ Metastatic Breast Cancer (MBC)

Primary outcome

Centrally Assessed Progression Free Survival (From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.); Overall Survival (From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT01808573 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Centrally Assessed Progression Free Survival

    Time frame
    From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
    Measure
    Mean
    Unit
    months

    • Neratinib Plus Capecitabine vs Lapatinib Plus CapecitabineSuperiority

      Estimate
      0.762Hazard Ratio (HR)
      95% CI, two-sided
      0.626 to 0.926
      p-value
      0.0059
      Method
      Log Rank

  2. Overall Survival

    Time frame
    From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.
    Measure
    Mean
    Unit
    months

    • Neratinib Plus Capecitabine vs Lapatinib Plus CapecitabineSuperiority

      Estimate
      0.881Hazard Ratio (HR)
      95% CI, two-sided
      0.723 to 1.073
      p-value
      0.2086
      Method
      Log Rank

Serious adverse events

Time frame: From time of first dose, through 28 days after last dose, assessed up to 41 months.

Participants with serious adverse events per group for NALA, as posted
GroupAffectedAt risk
Neratinib Plus Capecitabine103303
Lapatinib Plus Capecitabine93311

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. 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.

    Breast cancer research and treatment · 2021 Oct

    PubMed 34553296 (opens in a new tab)DOI 10.1007/s10549-021-06313-5 (opens in a new tab)

  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.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 Sep 20

    PubMed 32678716 (opens in a new tab)DOI 10.1200/JCO.20.00147 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.