Breast cancer
Conditions
Interventions
Experimental group:Neratinib was used as an adjuvant booster for 3 months in advance
Control group:Neratinib should be used within 12 months after the end of adjuvant therapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Eastern Cooperative Oncology Group (ECOG) physical status (PS) of 0-1; 3. Patients with histopathological confirmed early or locally advanced breast cancer, clinical stage II-III; 4. HER2 positive and HR negative (immunohistochemical estrogen receptor ER<1% and/or progesterone receptor PR<1%); 5. For patients who have not received neoadjuvant therapy at the beginning, axillary lymph node metastasis (pN+) must be met; 6. For patients who have received neoadjuvant therapy initially: postoperative pathology suggests that pathological complete remission has not been achieved, and postoperative T-DM1 treatment <=3 months; 7. Trastuzumab combined with pertuzumab treatment in the adjuvant stage, and there are still 3 months before the end of adjuvant therapy; 8. Volunteered to participate in the study and signed a written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Refusal to enroll in this study or refuse to cooperate with follow-up; 2.Patients who participated in other interventional studies within 4 weeks; 3. Metastatic disease (stage IV) or inflammatory breast cancer 4. Previous or current history of malignancy except for the following cured malignancies: basal cell and squamous cell carcinoma of the skin, carcinoma in situ of the cervix; 5. Clinically relevant cardiovascular disease: known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension >=180/110); 6. History of allergy to the drugs in this study; 7. Unable or unwilling to swallow tablets; 8. History of gastrointestinal disease with diarrhea as the main symptom.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Countries
China
Contacts
Public ContactYongqing Li
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed