Actively Recruiting
Pyrotinib Combined with Trastuzumab and Paclitaxel Chemotherapy for First-Line Treatment of HER2-Positive Advanced Breast Cancer A Randomized Study Comparing Different Pyrotinib Doses
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-01-13
200
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
T
The First People's Hospital of Xuzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different doses of Pyrotinib combined with trastuzumab and paclitaxel chemotherapy for the first-line treatment of HER2-positive advanced breast cancer. This phase 1 clinical study plans to enroll 200 adult patients diagnosed with HER2-positive advanced breast cancer, aiming to compare two dosing regimens between November 2024 and November 2026. Participants are randomly assigned to one of two groups: one receiving 320mg of Pyrotinib daily plus trastuzumab and docetaxel every 3 weeks, and the other receiving 400mg of Pyrotinib daily with the same trastuzumab and docetaxel schedule. Trastuzumab is administered intravenously at 8mg/kg in the first cycle and 6mg/kg in subsequent cycles, while docetaxel is given intravenously at 75mg/m2 every 3 weeks. During the study, participants will be monitored from treatment start until disease progression for up to 100 months. Researchers will assess the objective response rate to the treatment. Patients will undergo evaluations including physical fitness status, vital organ function tests, and other safety assessments. The study also tracks adverse effects and treatment adherence throughout the long follow-up period.
CONDITIONS
Official Title
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject voluntarily agrees to join the study and signs informed consent
- Adult male or female aged 18 to 75 years at consent
- HER2-positive advanced breast cancer confirmed by pathology with specific HER2 criteria
- Recurrent or metastatic breast cancer not suitable for curative surgery if locally recurrent
- At least one measurable lesion or bone-only metastases per RECIST v1.1
- Physical fitness status of 0 or 1 on the ECOG scale at randomization
- Vital organ function within defined laboratory limits including blood counts, liver and kidney function, heart function, and ECG parameters
You will not qualify if you...
- Prior systemic antitumor therapy for recurrence/metastasis including EGFR/HER2 agents, chemotherapy, immunotherapy, or more than first-line endocrine therapy
- Previous use of HER-targeting tyrosine kinase inhibitors or antibodies except adjuvant trastuzumab
- Less than 12 months from end of adjuvant systemic therapy to recurrence/metastasis diagnosis
- Active brain metastases needing treatment or with symptoms
- Peripheral neuropathy grade 3 or higher
- Deemed unsuitable for systemic chemotherapy by investigators
- Use of endocrine therapy within 7 days before randomization
- Other malignancies within 5 years except certain cured skin or cervical cancers
- Major surgery or trauma within 4 weeks before randomization or planned major surgery
- Serious heart diseases like heart failure, significant arrhythmias, valvular disease, or poorly controlled hypertension
- Conditions affecting drug intake like inability to swallow or intestinal obstruction
- Known allergies to study drug components
- History of immunodeficiency or organ transplant
- Uncontrolled fluid accumulation such as pleural effusion or ascites
- Pregnant or breastfeeding females or those unwilling to use contraception
- Serious concomitant diseases interfering with treatment or unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
Y
Yongmei Yin, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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