Evidence map›Paper›PMID 30860945›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases.

Rachel A Freedman, Rebecca S Gelman, Carey K Anders, Michelle E Melisko, Heather A Parsons, Anne M Cropp, Kelly Silvestri, Christine M Cotter, Kathryn P Componeschi, Juan M Marte and 21 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 226 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
226citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

226 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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166 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors.

Rachel A Freedman1 Dana-Farber Cancer Institute, Boston, MA.
Rebecca S Gelman1 Dana-Farber Cancer Institute, Boston, MA.
Carey K Anders2 University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michelle E Melisko3 University of California at San Francisco, San Francisco, CA.
Heather A Parsons1 Dana-Farber Cancer Institute, Boston, MA.
Anne M Cropp1 Dana-Farber Cancer Institute, Boston, MA.
Kelly Silvestri1 Dana-Farber Cancer Institute, Boston, MA.
Christine M Cotter1 Dana-Farber Cancer Institute, Boston, MA.
Kathryn P Componeschi1 Dana-Farber Cancer Institute, Boston, MA.
Juan M Marte1 Dana-Farber Cancer Institute, Boston, MA.
Roisin M Connolly4 Johns Hopkins School of Medicine, Baltimore, MD.
Beverly Moy5 Massachusetts General Hospital, Boston, MA.
Catherine H Van Poznak6 University of Michigan, Ann Arbor, MI.
Kimberly L Blackwell7 Duke University Medical Center, Durham, NC.
Shannon L Puhalla8 University of Pittsburgh Cancer Institute, Pittsburgh, PA.
Rachel C Jankowitz8 University of Pittsburgh Cancer Institute, Pittsburgh, PA.
Karen L Smith4 Johns Hopkins School of Medicine, Baltimore, MD.
Nuhad Ibrahim9 The University of Texas MD Anderson Cancer Center, Houston, TX.
Timothy J Moynihan10 Mayo Clinic, Rochester, MN.
Ciara C O'Sullivan10 Mayo Clinic, Rochester, MN.
Julie Nangia11 Baylor College of Medicine, Houston, TX.
Polly Niravath11 Baylor College of Medicine, Houston, TX.
Nadine Tung12 Beth Israel Deaconess Medical Center, Boston, MA.
Paula R Pohlmann13 Lombardi Comprehensive Cancer Center, Washington, DC.
Robyn Burns14 The Emmes Corporation, Rockville, MD.
Mothaffar F Rimawi11 Baylor College of Medicine, Houston, TX.
Ian E Krop1 Dana-Farber Cancer Institute, Boston, MA.
Antonio C Wolff4 Johns Hopkins School of Medicine, Baltimore, MD.
Eric P Winer1 Dana-Farber Cancer Institute, Boston, MA.
Nancy U Lin1 Dana-Farber Cancer Institute, Boston, MA.
Translational Breast Cancer Research Consortium

Funding

VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI A. Heather Eliassen · 1985 to 2026
$330.6M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA006516NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeEvidence-based treatments for metastatic, human epidermal growth factor receptor 2 (HER2)-positive breast cancer to the CNS are limited. We previously reported modest activity of neratinib monotherapy for HER2-positive breast cancer brain metastases. Here we report the results from additional study cohorts. PATIENTS AND

methodsPatients with measurable, progressive, HER2-positive brain metastases (92% after receiving CNS surgery and/or radiotherapy) received neratinib 240 mg orally once per day plus capecitabine 750 mg/m

resultsForty-nine patients enrolled in cohorts 3A (n = 37) and 3B (n = 12; cohort closed for slow accrual). In cohort 3A, the composite CNS ORR = 49% (95% CI, 32% to 66%), and the CNS ORR in cohort 3B = 33% (95% CI, 10% to 65%). Median progression-free survival was 5.5 and 3.1 months in cohorts 3A and 3B, respectively; median survival was 13.3 and 15.1 months. Diarrhea was the most common grade 3 toxicity (29% in cohorts 3A and 3B). Neratinib plus capecitabine is active against refractory, HER2-positive breast cancer brain metastases, adding additional evidence that the efficacy of HER2-directed therapy in the brain is enhanced by chemotherapy. For optimal tolerance, efforts to minimize diarrhea are warranted.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsCapecitabineCohort StudiesErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProgression-Free SurvivalQuinolinesSurvival RateCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesneratinibQuinolines

Identifiers

PMID30860945
PMCPMC6494354

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.