Actively Recruiting
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
Led by Peking Union Medical College Hospital · Updated on 2023-09-13
300
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
CONDITIONS
Official Title
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Primary invasive breast cancer confirmed by tissue analysis
- HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive) with lymph node positive except for T0, or lymph node negative with tumor size >1cm, or tumor between >0.5 cm and ≤1cm with high-risk factors
- Completed mastectomy or breast-conserving surgery and lymph node biopsy or dissection within 90 days
- Known estrogen receptor (ER) and progesterone receptor (PR) status
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate major organ function based on blood tests including neutrophil, platelet, hemoglobin, kidney, liver enzymes within specified limits
- Voluntarily agrees to participate and comply with study procedures
You will not qualify if you...
- Breast cancer recurrence or metastasis before enrollment
- Participation in other clinical trials within 4 weeks or 5 half-lives before enrollment
- Previous treatment with HER2-targeting tyrosine kinase inhibitors
- Diagnosis of other cancers within 5 years except cured cervical carcinoma in situ or certain skin cancers
- Receiving anti-tumor therapies from other clinical trials
- Difficulty swallowing, chronic diarrhea, or intestinal obstruction affecting drug absorption
- Recent major surgery unrelated to breast cancer within 4 weeks or incomplete recovery
- Allergy to study drugs or history of immunodeficiency, HIV, hepatitis, or organ transplant
- Pregnant or breastfeeding, or unwilling to use contraception during study
- Heart diseases including arrhythmia, heart attack, heart failure, or other unsuitable conditions
- Serious comorbidities like resistant hypertension, severe diabetes, or active infections
- History of neurological or mental disorders such as epilepsy or dementia
- Using drugs that affect CYP3A4 enzyme or prolong QT interval
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
X
Xuefei Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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