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
Cristina SauraNALA Investigators

Abstract

NALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens. Patients, including those with stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day) plus capecitabine (750 mg/m2 twice a day 14 d/21 d) with loperamide prophylaxis, or to lapatinib (1,250 mg once every day) plus capecitabine (1,000 mg/m2 twice a day 14 d/21 d). Coprimary end points were centrally confirmed progression-free survival (PFS) and overall survival (OS). NALA was considered positive if either primary end point was met (α split between end points). Secondary end points were time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL). A total of 621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314). Centrally reviewed PFS wa...Continue Reading

References

Dec 1, 1996·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·M T King
Dec 29, 2006·The New England Journal of Medicine·Charles E GeyerDavid Cameron
Oct 2, 2012·The New England Journal of Medicine·Sunil VermaUNKNOWN EMILIA Study Group
Dec 4, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nancy U LinPatricia S Steeg
Oct 8, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Cristina SauraSung-Bae Kim
Feb 19, 2015·The New England Journal of Medicine·Sandra M SwainUNKNOWN CLEOPATRA Study Group
Jul 15, 2016·The New England Journal of Medicine·John W ParkUNKNOWN I-SPY 2 Investigators
Jul 23, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoE P Winer
Mar 13, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rachel A FreedmanUNKNOWN Translational Breast Cancer Research Consortium
Aug 24, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jame AbrahamSamuel A Jacobs
Dec 12, 2019·The New England Journal of Medicine·Shanu ModiUNKNOWN DESTINY-Breast01 Investigators
Dec 12, 2019·The New England Journal of Medicine·Rashmi K MurthyEric P Winer

❮ Previous
Next ❯

Citations

Nov 27, 2020·Expert Opinion on Biological Therapy·Paolo TarantinoGiuseppe Curigliano
Nov 21, 2020·Expert Review of Pharmacoeconomics & Outcomes Research·Vakaramoko DiabyAskal Ali
Dec 18, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Cristina SauraAdam Brufsky
Dec 18, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew D SeidmanAki Morikawa
Dec 18, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Dun-Chang MoHan-Lei Wang
Dec 18, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Tim Johannes Adrianus Dekker
Dec 2, 2020·Biochimica Et Biophysica Acta. Reviews on Cancer·Paolo TarantinoGiuseppe Curigliano
Jan 21, 2021·Current Oncology·Leonor Vasconcelos de MatosFátima Vaz
Nov 18, 2020·International Journal of Molecular Sciences·Jorge Esteban-VillarrubiaJavier Molina-Cerrillo
Nov 12, 2020·Geburtshilfe und Frauenheilkunde·Elena LaakmannAndreas D Hartkopf
Feb 27, 2021·Breast Cancer Research and Treatment·Paolo Tarantino, Giuseppe Curigliano
Mar 25, 2021·Expert Opinion on Biological Therapy·Jose PerezJavier Cortés
Mar 27, 2021·Nature Reviews. Clinical Oncology·Bishal Gyawali, Aaron S Kesselheim
Mar 26, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Alvaro Moreno-AspitiaUNKNOWN ALTTO Steering Committee and Investigators
Apr 5, 2021·Lancet·Sibylle LoiblGiuseppe Curigliano
May 28, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nicolò Matteo Luca BattistiAlistair Ring
Jun 3, 2021·JCO Oncology Practice·Olga Martínez-Sáez, Aleix Prat
Jun 3, 2021·JCO Oncology Practice·Paolo TarantinoGiuseppe Curigliano
May 29, 2021·Cancer Treatment Reviews·Edoardo CriminiGiuseppe Curigliano
May 26, 2021·Clinical Breast Cancer·Jacob S WittBethany M Anderson
Jun 4, 2021·Breast Cancer : Targets and Therapy·Lara Ulrich, Alicia F C Okines
Jun 20, 2021·Bulletin du cancer·Benoîte MeryOlivier Trédan
Jun 22, 2021·Future Oncology·Elissar MoujaessHampig Raphael Kourie
Jun 26, 2021·Breast Cancer Research and Treatment·Matthew KearneyKevin Kalinsky
Jul 3, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Volkmar MuellerKaren Gelmon
Jul 3, 2021·Cancers·Alejandro Garcia-AlvarezMafalda Oliveira
Jul 3, 2021·Cancers·Ryan W Holloway, Paola A Marignani
Jul 8, 2021·Pharmaceutical Statistics·Yi ZhongBin Yao
Jul 20, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Fanny Le DuGiuseppe Curigliano

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT00567190
NCT00829166
NCT01419197
NCT00078572
NCT00878709
NCT00915018
NCT02400476
NCT00967031
NCT01494662
NCT01808573

Software Mentioned

SAS
ExteNET
NEfERT

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.