drugset / Trial / NCT05474690

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

NCT05474690 ↗

Phase 3 Withdrawn Henan Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-11
Primary completion
2023-03-28
Completion
2024-08-30

Outcome

Outcome not reported

Stopped: “The new treatment plan for HER2 positive breast cancer has entered the diagnosis and treatment guide. The treatment plan ECHP-THP in this study is not the optimal treatment plan, therefore this study was terminated.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule — —
Subject Cyclophosphamide Other / unclassified 600 mg/m2 —
Comparator Docetaxel Small molecule 75 mg/m2 —
Comparator Docetaxel Small molecule 90 mg/m2 —
Subject Epirubicin Small molecule 90 mg/m2 —
Comparator Pertuzumab Monoclonal antibody 420 mg —
Comparator Trastuzumab Monoclonal antibody 6 mg/kg —