Locally Advanced Breast Cancer
Conditions
Brief summary
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Interventions
DRUGpyrotinib
pyrotinib 400 mg, orally once daily for one year
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female, Aged ≥18 and ≤70 years; * Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ; * Completed neoadjuvant therapy, including chemotherapy and trastuzumab; * Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy; * Been or being treated for early breast cancer with standard of care duration of trastuzumab; * Adjuvant treatment regimen needs to be determined before randomization; * Duration from Random time to the last use of trastuzumab≤1 year. * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; * Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: \< 470 ms * Signed informed consent form (ICF) .
Exclusion criteria
* Metastatic disease (Stage IV) ; * Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; * Progressive disease during neoadjuvant therapy; * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; * Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib. * Less than 4 weeks from the last clinical trial; * History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; * Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial; * Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-free Survival (iDFS) | From randomization until time of event up to 2 years. | Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) | From randomization until time of event up to 2 years | Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause |
| Overall Survival (OS) | From randomization until time of event up to 2 years | Overall survival is defined as the time from randomization to death from any cause. |
Countries
China
Contacts
Primary ContactWenjin Yin
Backup ContactQi Lu
Outcome results
None listed