Actively Recruiting
A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Led by Henan Cancer Hospital · Updated on 2024-09-20
688
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
CONDITIONS
Official Title
A Comparison of Nab-PHP and TCbHP Efficacy 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 positive axillary lymph nodes
- Histopathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with confirmed gene amplification)
- Measurable lesions on ultrasound, mammography, or optional MRI within 1 month before randomization
- Adequate organ and bone marrow function: neutrophil count 9 2.0 x 10^9/L or higher; hemoglobin 100 g/L or higher; platelet count 100 x 10^9/L or higher; total bilirubin less than 1.5 times the upper limit of normal; creatinine less than 1.5 times upper limit; AST/ALT less than 1.5 times upper limit
- Left ventricular ejection fraction 55% or higher by cardiac ultrasound
- Negative serum pregnancy test within 14 days before randomization for women of reproductive age
- ECOG performance status 0 or 1
- Signed informed consent form
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Bilateral breast cancer
- Prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease
- Second primary malignancy except adequately treated skin cancer
- Major non-breast cancer surgery within 4 weeks before enrollment or incomplete recovery from such surgery
- Severe heart disease or conditions preventing study participation, including history of heart failure or systolic dysfunction (LVEF below 50%), high-risk uncontrolled arrhythmias, angina requiring treatment, significant valvular heart disease, prior transmural myocardial infarction on ECG, or uncontrolled hypertension (systolic >180 mmHg or diastolic >100 mmHg)
- Severe uncontrolled medical conditions contraindicating chemotherapy
- Known allergy to any study drug components
- History of immune deficiency diseases, including HIV, or organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Z
Zhenzhen Liu
CONTACT
J
Jiujun Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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