Actively Recruiting
Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
Led by zhangjie · Updated on 2025-01-01
60
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC
CONDITIONS
Official Title
Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years old
- Pathologically confirmed HER2-positive invasive breast cancer
- Imaging confirms recurrent or metastatic breast cancer
- Recurrence or metastasis more than 1 year after trastuzumab treatment or newly diagnosed stage IV breast cancer
- ECOG performance status 0-1
- Expected survival of at least 6 months
- Normal major organ function
- Blood routine: ANC ≥1.5×10⁹/L; PLT ≥90×10⁹/L; Hb ≥90 g/L
- Blood biochemistry: TBIL ≤1.5×ULN; ALT and AST ≤2×ULN (≤5×ULN if liver metastases); BUN and creatinine ≤1.5×ULN; creatinine clearance ≥50 mL/min
- Heart ultrasound: LVEF ≥50%
- Investigator believes subject may benefit
- Voluntary participation with signed informed consent
You will not qualify if you...
- Brain metastases confirmed by head MRI or CT
- Conditions affecting oral medication intake (e.g., gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction)
- Allergy to study drugs or excipients
- Mental illness or psychotropic substance abuse preventing cooperation
- Pregnant or breastfeeding women
- Participation in other clinical trials within 4 weeks
- Considered unsuitable for inclusion by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fujian Union Medical College Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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