Actively Recruiting
Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Led by Henan Cancer Hospital · Updated on 2025-07-09
812
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
CONDITIONS
Official Title
Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Clinical tumor stage T2 to T4d or T1c with axillary lymph node positivity
- Histologically confirmed HER2-positive invasive breast cancer
- Tumor measurable by ultrasound or optional MRI within one month before randomization
- Adequate organ and bone marrow function within one month before starting chemotherapy
- Left ventricular ejection fraction (LVEF) 55% or higher by echocardiography
- Negative pregnancy test within 14 days before randomization for women of childbearing potential
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed written informed consent
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Bilateral breast cancer
- Prior systemic therapy or radiotherapy for current breast cancer diagnosis
- History of a second primary malignancy except treated non-melanoma skin cancer or cervical carcinoma in situ
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or incomplete recovery
- Significant cardiac disease or dysfunction including history of heart failure, uncontrolled arrhythmias, angina requiring medication, valvular heart disease, myocardial infarction evidence, or poorly controlled hypertension
- Any other severe uncontrolled medical condition contraindicating chemotherapy
- Known allergy to any study drug component
- History of immune deficiency diseases, including HIV, or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Z
Zhenzhen Liu, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here