NCT03289039

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

A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has approved Neratinib as a treatment for breast cancer. Fulvestrant has been FDA approved for treatment of metastatic hormone receptor positive breast cancer. The purpose of this research study is to determine how well neratinib, by itself or together with Fulvestrant, works in treating breast cancer that has spread to other parts of the body. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). Neratinib has been used in other research studies and information from those other research studies suggests that neratinib may help to shrink or stabilize HER2-positive breast cancer in this research study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Neratinib	Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)
DRUG	Fulvestrant	Fulvestrant, works in treating breast cancer that has spread to other parts of the body

Timeline

• Start date: 2017-10-25
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2017-09-20
• Last updated: 2026-01-22
• Results posted: 2023-03-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study