Breast Cancer Invasive
Conditions
Brief summary
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Interventions
DRUGpyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18; * Histologically confirmed invasive HER2 positive breast cancer; * Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years; * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; * Adequate organ functions.
Exclusion criteria
* Metastatic disease (Stage IV); * Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; * Treated or treating with anti-HER2 tyrosine kinase inhibitor; * 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; * 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. |
| Adverse events | From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year) | Adverse events will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Backup ContactQi Lu
Outcome results
None listed