Actively Recruiting
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
Led by Youzhi Zhu · Updated on 2025-03-12
30
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
CONDITIONS
Official Title
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-75 years
- HER2-positive breast cancer confirmed by pathology
- Invasive breast cancer confirmed by histology with tumor stage early (T1c-3, N0-1, M0) or locally advanced (T2-4, N2, N3, M0)
- ECOG performance status of 0 or 1
- Plan to undergo breast cancer surgery (breast conserving surgery or total mastectomy) with lymph node evaluation
- Normal major organ function meeting specific blood counts and biochemical criteria
- For premenopausal women or those without surgical sterilization, agreement to use effective contraception during treatment and for 7 months after
- Willing to volunteer, sign informed consent, comply with study requirements, and cooperate with follow-up
You will not qualify if you...
- Known allergy to study drug components
- Previous or current other malignant tumors except cured basal cell carcinoma or cervical carcinoma in situ
- Participation in other antitumor drug trials within 4 weeks
- Stage IV (metastatic) breast cancer
- Conditions affecting oral medication intake such as swallowing problems or gastrointestinal issues
- History of congestive heart failure or uncontrolled heart disease
- Active infection or severe mental illness
- Pregnancy or breastfeeding
- History of immunodeficiency or organ transplantation
- Any other serious disease or condition that could endanger safety or interfere with study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujan Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
Z
zhu youzhi
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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