Actively Recruiting
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Led by Hebei Medical University Fourth Hospital · Updated on 2024-02-28
100
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
CONDITIONS
Official Title
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years
- Pathologically confirmed HER2-positive invasive breast cancer
- Imaging confirmed recurrent or metastatic breast cancer
- Relapse or metastasis occurring at least 3 months after stopping Trastuzumab treatment
- At least one measurable lesion based on RECIST 1.1 criteria
- ECOG performance status score between 0 and 2
- Expected life expectancy of 3 months or more
- Normal major organ function
- Considered likely to benefit by the researcher
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of severe drug allergies or allergic reactions to study drugs (grade > 3)
- Previous systemic treatment in advanced stages
- History of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia, or myocardial infarction
- Serious lung diseases including interstitial lung disease, pneumonia, pulmonary fibrosis, or acute pulmonary conditions
- Severe liver diseases like acute hepatitis, explosive hepatitis, or coagulation factor disorders
- Positive for HBV surface antigen or core antibody without a low HBV DNA titer (< 1 × 10^3 IU/ml)
- Other medical conditions or comorbidities that may interfere with participation or safety, including active infections or liver/gallbladder diseases requiring antiviral treatment
- Presence of other invasive tumors, including second primary breast cancer
- Major surgery or recovery from major internal diseases within 4 weeks prior to study
- Any other condition deemed by the researcher to make the participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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