18 and older, any sex, with HER2 Amplified Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes in Colon PathologyPrimary· From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.
The primary endpoint is to describe the changes in colon pathology between the baseline colonoscopy and the second colonoscopy.
No Significant Findings
Group
Value
95% CI
Neratinib Patients With 2 Colonoscopies
2
Mild Changes
Group
Value
95% CI
Neratinib Patients With 2 Colonoscopies
2
Incidence and Severity of DiarrheaSecondary· From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.
Incidence and severity of treatment emergent (TEAE) diarrhea will be summarized according to the NCI-CTCAE version 4.0 in the first cycle of neratinib treatment, which is from the time of the first colonoscopy to the second colonoscopy, or 28 days for subjects with only one colonoscopy. Incidence is defined as the number of patients experiencing diarrhea divided by the number of patients at risk.
TEAE Diarrhea
Group
Value
95% CI
Safety
80
Serious Diarrhea
Group
Value
95% CI
Safety
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From time of first dose, through 28 days after last dose, assessed up to 16 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06813079 — Using Tumor Models to Determine Treatments
· Phase 2
· not yet recruiting
NCT05919108 — Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
· Phase 2
· recruiting
NCT05491057 — Treatment Patterns of Neratinib in HER2+ EBC in China
· not yet recruiting
NCT05243641 — Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients W
· Phase 1, PHASE2
· terminated
NCT04886531 — Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
· Phase 2
· recruiting
Other Puma Biotechnology, Inc. trials
Trials by the same sponsor.
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
· Phase 2
· not yet recruiting
NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta
· Phase 2
· recruiting
NCT06095505 — A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
· Phase 2
· recruiting
NCT03786107 — HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research St
· terminated
NCT01953926 — Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Puma Biotechnology, Inc.
Last refreshed: 10 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04366713.