Phase 2 N=563 Treatment

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Early Stage HER2+ Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02400476 ↗

Enrolled (actual)

563

Serious AEs

6.2%

Results posted

May 2022

Primary outcome: Primary: Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0. — 30.7; 28.1; 20.6; 32.7 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Neratinib (Drug); Loperamide (Drug); Colestipol (Drug); Budesonide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Puma Biotechnology, Inc.
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.	30.7; 28.1; 20.6; 32.7; 13.3; 27.4	—
SECONDARY Percentage of Patients With Diarrhea by Grade, According to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), Version 4.0.	24.1; 23.4; 27.9; 32.7; 40.0; 37.1	—
SECONDARY Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest	6.57; 6.25; 6.62; 2.88; 8.33; 8.06	—

Summary

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

Eligibility Criteria

Inclusion Criteria

Age ≥18; male or female
Early breast cancer (stage I-3c)
Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+
Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment
No evidence of local/regional recurrence or metastatic disease
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception
Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO

Exclusion Criteria

Major surgery 0.450 seconds (males) or >0.470 (females) or other active cardiac disease
Significant chronic GI disorder with diarrhea as a major symptom
Active, unresolved infections
Currently pregnant or breast-feeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02400476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.