NCT07220135

Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer

A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive early breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	All of the treatment being received by the study participants during the course of the study is standard of care.
DRUG	Docetaxel	All of the treatment being received by the study participants during the course of the study is standard of care.
DRUG	Trastuzumab (or biosimilar)	All of the treatment being received by the study participants during the course of the study is standard of care.
DRUG	Pertuzumab (or biosimilar)	All of the treatment being received by the study participants during the course of the study is standard of care.

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-11-14
• Completion: 2031-05-14
• First posted: 2025-10-23
• Last updated: 2025-10-23

Regulatory

• FDA-regulated drug study