Actively Recruiting
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study
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
Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.
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
AI-Powered 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
CONTACT
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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