A Study Comparing the Efficacy of TCbHP & ECHP-THP in the Neoadjuvant

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05474690
Study type	Interventional
Source	Henan Cancer Hospital
Contact
Status	Withdrawn
Phase	Phase 3
Start date	May 11, 2022
Completion date	August 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms