NCT04901299

Fulvestrant + Neratinib In Breast Cancer

An Open-Label Phase II Trial of Fulvestrant And Neratinib in Previously Treated HRPositive, HER2-Negative Metastatic Breast Cancer Subjects Assessed With a Test Measuring Live Cell HER2 Signaling Function

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 open label, multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive, HER2-negative breast cancer. * This research study involves the study drug Neratinib * The standard of care drug Fulvestrant

Detailed description

* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * This research study involves the study drug Neratinib * The standard of care drug Fulvestrant * It is expected that about 25 people will take part in this research study. * This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. * The U.S. Food and Drug Administration (FDA) has not approved Neratinib for this specific disease but it has been approved for other uses. * The FDA has approved Fulvestrant as a treatment option for this disease. Fulvestrant is a standard of care drug that will be administered.

Conditions

• Stage IV (Metastatic) Breast Cancer
• Metastatic Breast Cancer
• ER Positive Breast Cancer
• PR-Positive Breast Cancer
• HER2-negative Breast Cancer
• Invasive Breast Cancer

Interventions

Type	Name	Description
DRUG	NERATINIB	Neratinib will be given orally once daily on a continuous daily dosing schedule i.e., no break in dosing. Dosage per protocol
DRUG	FULVESTRANT	Fulvestrant will be given via injection every two weeks for the first 28-day cycle and every four weeks thereafter, dosage per protocol

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-05-25
• Last updated: 2023-08-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study