NCT04886531

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruth O'Regan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• ER Positive Breast Cancer
• PR-Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Neratinib	120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily\*.
DRUG	Letrozole (L) or Anastrozole (A)	L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)\*
DRUG	Trastuzumab	All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.

Timeline

• Start date: 2022-07-21
• Primary completion: 2026-06-22
• Completion: 2027-07-21
• First posted: 2021-05-14
• Last updated: 2026-04-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study