Actively Recruiting
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-02-12
102
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
Z
Zhongda Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer
CONDITIONS
Official Title
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant voluntarily agrees to join and signs informed consent
- Female aged between 18 and 70 years at consent
- Confirmed HER2-positive advanced breast cancer by pathology with specific staining or FISH criteria
- Stage IV breast cancer by AJCC 8th edition
- No prior systemic antitumor therapy for recurrence/metastasis
- At least one measurable tumor lesion per RECIST 1.1
- ECOG physical status score of 0 or 1 at randomization
- Adequate vital organ function with specified blood counts, liver, kidney, thyroid, and albumin values as defined
You will not qualify if you...
- Previous treatment with any HER2-targeted tyrosine kinase inhibitors
- Active central nervous system metastases without surgery or radiation, except stable for 1 month and off corticosteroids >2 weeks
- Pial metastasis confirmed by MRI or lumbar puncture
- Inflammatory breast cancer or other malignancies within 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Any antitumor therapy within 4 weeks before enrollment
- Pregnant or breastfeeding women or positive pregnancy test within 14 days before first dose
- Gastrointestinal diseases significantly affecting drug absorption
- Symptomatic ascites, pleural or pericardial effusion requiring drainage at baseline or within 4 weeks prior
- History of immunodeficiency, including HIV positive or organ transplantation
- Major surgery or significant trauma within 4 weeks before treatment or planned major surgery
- Severe concurrent medical conditions endangering safety or study completion
- Inability to understand or follow study instructions
- Investigator's judgment that patient is unsuitable for study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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