Evidence map›Paper›PMID 39187401›Full record

Trial reportPhysiological reports2024

Preclinical and clinical evaluation through serial colonoscopic evaluation of neratinib-induced diarrhea in HER2-positive breast cancer-A pilot study.

Joanne Bowen, Sofia Braga, Valeria Dal Zotto, John Finnie, Daniel DiPrimeo, Blaire Cooke, Georg F Bischof, Alvin Wong, Jack A Di Palma

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Physiological reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04366713 (An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT04366713 phase2completednot on this map

An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

TypeinterventionalSponsorPuma Biotechnology, Inc.Ran2020 to 2021Enrolled6ConditionsHER2 Amplified Breast CancerArmsNeratinib, Capecitabine, Loperamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Joanne BowenSchool of Biomedicine, The University of Adelaide, Adelaide, South Australia, Australia.ORCID 0000-0003-0876-0031
Sofia BragaMedical Oncology, Hospital Prof. Doutor Fernando Fonseca, EPE, Amadora, Portugal.
Valeria Dal ZottoDepartment of Pathology, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
John FinnieDivision of Research and Innovation, University of Adelaide, Adelaide, South Australia, Australia.
Daniel DiPrimeoPuma Biotechnology, Inc., Los Angeles, California, USA.
Blaire CookePuma Biotechnology, Inc., Los Angeles, California, USA.
Georg F BischofPuma Biotechnology, Inc., Los Angeles, California, USA.
Alvin WongPuma Biotechnology, Inc., Los Angeles, California, USA.
Jack A Di PalmaDivision of Gastroenterology, University of South Alabama, College of Medicine, Mobile, Alabama, USA.

Funding

Puma Biotechnology (Puma Biotechnology, Inc.)
6 · The paper itself

Abstract

The irreversible pan-HER tyrosine kinase inhibitor neratinib is approved for patients with HER2-positive, early-stage and metastatic breast cancer (BC). Neratinib-associated diarrhea is the most common reason for early discontinuation. Preclinical studies identified mechanisms of neratinib-induced diarrhea and rationale for prophylactic and preventive measures. We studied effects of neratinib on rat intestines and conducted a phase 2 study of colon pathogenesis in patients with HER2-positive BC treated with neratinib (NCT04366713). Colon samples from female albino Wistar rats receiving neratinib or vehicle were examined for histopathological changes. Patients with HER2-positive BC received neratinib 240 mg once daily for up to 1 year. Colonoscopy biopsies were collected at baseline and at Day 28 to identify changes consistent with rat pathologies. Rat colons were markedly altered in appearance, with similar short circuit currents (I

Indexed as

Breast NeoplasmsColonoscopyDiarrheaErb-b2 Receptor Tyrosine KinasesQuinolinesRats, WistarAgedAnimalsAntineoplastic AgentsColonFemaleHumansMiddle AgedPilot ProjectsRatsAntineoplastic AgentsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesneratinibQuinolinescolonoscopy studydiarrheaHER2‐positive breast cancerneratinibrat model

Identifiers

PMID39187401
PMCPMC11347019

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.