HER2-positive Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGPyrotinib
Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily participate in this study and sign the informed consent form； 2. Female or male patients, aged ≥ 18 years, and ≤75 years; 3. ECOG PS score: 0-1; 4. Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH). 5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery. 6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1. 7. Could have been treated neoadjuvantly but have not reached pathologic complete response.
Exclusion criteria
1. metastatic disease (Stage IV) or inflammatory breast cancer 2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. 3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. A history of allergy to the drugs in this study； 5. Unable or unwilling to swallow tablets 6. History of gastrointestinal disease with diarrhea as the major symptom.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-free Survival (iDFS) at year 2 | From enrollment until time of events up to 2 years | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival at year 2 (2y-DFS) | From enrollment until time of events up to 2 years | Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause. |
| Overall Survival (OS) | Enrollment until death due to any cause, up to 10 years | Randomization to death from any cause |
| Invasive Disease-free Survival (iDFS) at year 5 | From enrollment until time of events up to 5 years | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause. |
| AEs and SAEs | From the first administration to one months after the last drug administration | Adverse events and Adverse events and serious adverse events according to CACTE 5.0 |
Countries
China
Contacts
Primary ContactXiaoan Liu, Professor
Outcome results
None listed