Actively Recruiting
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-04-28
188
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
CONDITIONS
Official Title
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily agree to take part and sign informed consent
- Female or male patients aged 18 to 75 years
- ECOG performance status score of 0 or 1
- HER2-positive early or locally advanced breast cancer confirmed by histopathology with IHC 3+ or IHC 2+ and positive ISH
- Stage II through IIIC HER2-positive breast cancer with lymph node involvement after surgery
- Completed standard trastuzumab combined with pertuzumab or T-DM1 treatment for early breast cancer
- May have received neoadjuvant therapy but did not achieve a complete pathological response
You will not qualify if you...
- Metastatic (Stage IV) or inflammatory breast cancer
- Previous or current malignant tumors except for treated basal and squamous skin cancer or carcinoma in situ of the cervix
- Significant cardiovascular disease including uncontrolled angina, serious arrhythmias, heart failure, heart attack, or uncontrolled high blood pressure
- Known allergy to study drugs
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the main symptom
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xiaoan Liu, Professor
CONTACT
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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