Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

Summary

This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: * Neratinib and Fulvestrant * Neratinib alone

Timeline

Start

2017-10-25

Primary completion

2021-07-20

Completion

2021-07-20

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow accrual”

registry analysis (superiority test); Neratinib vs Neratinib + Fulvestrant; p = 0.98; Hazard Ratio (HR) 1.06 (95% CI 0.27 to 4.12); Log Rank NCT03289039 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Neratinib	Small molecule	240 mg	Oral

Indications