Actively Recruiting
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-02-26
312
Participants Needed
1
Research Sites
407 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are: * Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP. * Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment. Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab. Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.
CONDITIONS
Official Title
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years with metastatic breast cancer confirmed by pathology or imaging
- HER2 positive status confirmed by pathology (IHC 3+, or IHC 2+ with FISH amplification)
- No prior chemotherapy for metastatic breast cancer
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status score of 0 to 2 and expected survival of at least 3 months
- Previous treatment toxicities resolved to grade 1 or less (except alopecia or non-safety risks)
- Adequate white blood cell count (WBC 23 3.0 x 10^9/L), neutrophils (ANC 21.5 x 10^9/L), and platelets (PLT 23 70 �d7 10^9/L)
- Normal liver, kidney, and heart function tests within specified limits
- Left ventricular ejection fraction (LVEF) 23 55% and QTcF 23 470 ms
- Known hormone receptor status
- Negative pregnancy test for women of childbearing potential and agreement to use effective non-hormonal contraception during and 6 months after treatment
- Ability to understand the study and provide informed consent
You will not qualify if you...
- HER2 negative pathology (IHC 2+ and FISH-, or IHC 1+)
- Known allergy to study drugs or their components
- Pregnancy, breastfeeding, positive pregnancy test at baseline, or unwillingness to use contraception
- Any serious medical condition or uncontrolled disease that may affect safety or study participation, including uncontrolled heart disease, high blood pressure, active infections, or active hepatitis B infection
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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