NCT05474690

A Study Comparing the Efficacy of TCbHP and ECHP-THP in the Neoadjuvant Treatment of HER2-positive Breast Cancer

A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In 2020, the incidence of breast cancer surpassed that of lung cancer for the first time, becoming the number one cancer in the world. HER2 is an important prognostic indicator and therapeutic target for breast cancer. HER2-overexpressing breast cancer accounts for about 20% to 30% of all breast cancer patients. Targeted therapy for HER2 protein is the core treatment for this type of breast cancer. At present, the neoadjuvant treatment mode of trastuzumab and pertuzumab dual-target chemotherapy has become the standard neoadjuvant treatment for high-risk HER2-positive breast cancer. For patients with early-stage high-risk or locally advanced HER2-positive breast cancer, whether standard neoadjuvant regimen without anthracycline can achieve the same therapeutic effect compared with regimen containing anthracycline is still inconclusive.Therefore, this study aimed to compare the efficacy and safety of two neoadjuvant treatment regimens, TCbHP\*6 and ECHP\*4-THP\*4, in the neoadjuvant treatment of HER2-positive breast cancer through a randomized controlled phase 3 clinical trial.

Detailed description

Subjects were screened according to inclusion and exclusion criteria. Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1. Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative). 1. Drug dose of TCbHP regimen: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + Pascal Tocilizumab (initial loading dose of 840 mg, followed by maintenance dose of 420 mg), every 21 days as a cycle. 2. Dosage of ECHP-THP regimen: epirubicin 90mg/m2 + cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (the first loading dose of 8 mg/kg, followed by maintenance The dose is 6 mg/kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel + Carboplatin + Trastuzumab + Pertuzumab	Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1. Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative). TCbHP regimen drug dose: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + pertuzumab Antibiotics (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.
DRUG	(Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)	Dosage of ECHP-THP regimen: epirubicin 90mg/m2+cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg /kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-03-28
• Completion: 2024-08-30
• First posted: 2022-07-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: China