Actively Recruiting
Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-02-18
33
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status of 0 to 1
- Histologically confirmed invasive HER2-positive breast cancer with stages T1N1-3M0 or T2-4N0M0
- HER2 positivity defined by immunohistochemistry 3+ or gene amplification according to ASCO/CAP 2013 guidelines
- Adequate organ function including blood counts, liver and kidney tests within specified limits
- Left ventricular ejection fraction greater than 55%
- Corrected QT interval less than 470 milliseconds on ECG
- Effective contraception for premenopausal or non-sterilized women during and for 6 months after treatment
- Willingness to provide informed consent and comply with study follow-up
You will not qualify if you...
- Stage IV or inflammatory breast cancer
- Prior anti-tumor treatment or radiation for any malignant tumor except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Concurrent participation in other anti-tumor clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before starting study treatment or incomplete recovery from such surgery
- Serious heart disease including heart failure, uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, myocardial infarction on ECG, or poorly controlled hypertension
- Active uncontrolled infections or history of immunodeficiency including HIV or organ transplantation
- Chronic active hepatitis B or active hepatitis C infection
- Known allergies to components of the study medications
- Pregnancy, lactation, or unwillingness to use effective contraception during and for 6 months after the study
- Serious comorbidities or other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
Research Team
Z
Zhi-jun Dai
CONTACT
J
Jin-fei Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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