Trial reportBreast cancer research : BCR2019
Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial.
Trial report in Breast cancer research : BCR, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00878709 (A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib), which is not on this map. Cited by 23 papers.
What it found
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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.
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.
A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
Who cites it
23 citing papers in PubMed, 33 citations in OpenAlex.
- Preclinical and clinical evaluation through serial colonoscopic evaluation of neratinib-induced diarrhea in HER2-positive breast cancer-A pilot study.Physiological reports · 2024Trial
- Longitudinal evaluation of health-related quality of life in Chinese patients with early-stage HER2-positive breast cancer undergoing neratinib extended adjuvant therapy: a real-world prospective cohort study.Frontiers in oncology · 2026Article
- Review
- Case report: Near-complete response to neratinib-based treatment in HR-positiveFrontiers in oncology · 2024Article
- Cost-effectiveness of abemaciclib plus endocrine therapy in high-risk HR+/HER2-early breast cancer in China.Cost effectiveness and resource allocation : C/E · 2023Article
- Neratinib for HER2-positive breast cancer with an overlooked option.Molecular medicine (Cambridge, Mass.) · 2023Review
- Final findings from the CONTROL trial: Strategies to reduce the incidence and severity of neratinib-associated diarrhea in patients with HER2-positive early-stage breast cancer.Breast (Edinburgh, Scotland) · 2023Article
- Economic evaluation of third-line neratinib plus capecitabine versus lapatinib plus capecitabine with HER2+ metastatic breast cancer.Frontiers in oncology · 2023Article
- The Pharmacokinetics and Safety of Tucatinib in Volunteers with Hepatic Impairment.Clinical pharmacokinetics · 2022Article
- Management of Diarrhea in Patients with HER2-Positive Breast Cancer Treated with Neratinib: A Case Series and Summary of the Literature.Oncology and therapy · 2022Article
- Case Report: Neratinib Therapy Improves Glycemic Control in a Patient With Type 2 Diabetes and Breast Cancer.Frontiers in endocrinology · 2022Article
- Role of ErbB1 in the Underlying Mechanism of Lapatinib-Induced Diarrhoea: A Review.BioMed research international · 2022Review
- Position Paper on the Value of Extended Adjuvant Therapy with Neratinib for Early HER2+/HR+ Breast Cancer.Breast care (Basel, Switzerland) · 2021Review
- How to Optimise Extended Adjuvant Treatment with Neratinib for Patients with Early HER2+ Breast Cancer.Oncology and therapy · 2021Review
- Trans-(-)-Kusunokinin: A Potential Anticancer Lignan Compound against HER2 in Breast Cancer Cell Lines?Molecules (Basel, Switzerland) · 2021Article
- Tucatinib Inhibits Renal Transporters OCT2 and MATE Without Impacting Renal Function in Healthy Subjects.Journal of clinical pharmacology · 2021Article
- Cost-Effectiveness Analysis of Abemaciclib Plus Fulvestrant in the Second-Line Treatment of Women With HR+/HER2- Advanced or Metastatic Breast Cancer: A US Payer Perspective.Frontiers in medicine · 2021Article
- Analysis of Gut Microbiome Using Explainable Machine Learning Predicts Risk of Diarrhea Associated With Tyrosine Kinase Inhibitor Neratinib: A Pilot Study.Frontiers in oncology · 2021Article
- The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer.Breast cancer research and treatment · 2020Article
- Tyrosine kinase inhibitor neratinib attenuates liver fibrosis by targeting activated hepatic stellate cells.Scientific reports · 2020Article
Corrections and comments
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Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe characterized patterns of occurrence and the impact of neratinib-associated diarrhea in the absence of protocol-directed antidiarrheal prophylaxis or a formal diarrhea management plan using data from Extended Adjuvant Treatment of Breast Cancer with Neratinib (ExteNET).
methodsExteNET is a multicenter, double-blind, placebo-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months. Safety, a secondary outcome, was assessed using the National Cancer Institute Common Terminology Criteria version 3.0. Health-related quality of life by diarrhea grade was assessed using Functional Assessment of Cancer Therapy-Breast (FACT-B).
resultsTwo thousand eight hundred sixteen women (1408 per group) were safety-evaluable. Grade 3 and 4 diarrhea occurred in 561 (39.8%) and 1 (0.1%) patients with neratinib versus 23 (1.6%) and 0 patients with placebo, respectively. In the neratinib group, 28.6% of patients had grade 3 events during month 1 decreasing to ≤ 6% after month 3. The median cumulative duration of grade 3/4 diarrhea with neratinib was 5 days (interquartile range, 2-9). Serious diarrheal events (n = 22, 1.6%) and diarrheal events requiring hospitalization (n = 20, 1.4%) were rare with neratinib. Changes in FACT-B total score by diarrhea grade in the neratinib group did not meet the threshold for clinically important differences.
conclusionsIn the absence of antidiarrheal prophylaxis, neratinib-related diarrhea is short-lived and not associated with complications or long-term sequelae. This suggests that targeted preventive management with antidiarrheal prophylaxis early during neratinib treatment is appropriate.
trial registrationClinicalTrials.gov NCT00878709. Registered 9 April 2009.
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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.