RecruitingPhase 2NCT06832904

Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)

Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05): A Prospective, Single-arm, Multi-center Clinical Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

33 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR)and clinical complete response(cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (NEOTORCH-BREAST05) is testing a combination of two HER2-targeted drugs — pyrotinib and trastuzumab — added to standard chemotherapy as a pre-surgery treatment (neoadjuvant therapy) for HER2-positive breast cancer. The goal is to shrink the tumor before surgery for better outcomes. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with HER2-positive invasive breast cancer confirmed by pathology - Your cancer stage meets specific criteria (T1 with node involvement, or T2–T4 with or without node involvement, without distant spread) - Your performance status (ECOG score) is 0 or 1 - Your major organ function (blood, heart, liver) meets required levels **You may NOT be eligible if...** - You have already received treatment for this breast cancer - You have metastatic (Stage 4) disease - Your heart function or other organ function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGpyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy

Receive four neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) , nab-paclitaxel (260 mg/m2) and carboplatin(AUC=5)every 3 weeks.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06832904


Related Trials