Breast Cancer
Conditions
Brief summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Interventions
DRUGPyrotinib
pyrotinib 400 mg, orally once daily for one year
DRUGPlacebo
placebo 400mg, orally once daily for one year
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Pyrotinib versus Placebo
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female patients, 18 years ≤ age ≤ 75 years； * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive HER2 positive breast cancer. * Known hormone receptor status. * Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram. * Been treated for early breast cancer with standard of care duration of trastuzumab. * If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response. * Signed informed consent form (ICF) .
Exclusion criteria
* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. * History of heart disease. * Bilateral breast cancer. * Corrected QT (QTc) interval ≥0.47 seconds. * History of gastrointestinal disease with diarrhea as the major symptom.
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) | up to 2 years | Overall survival is defined as the time from randomization to death from any cause. |
| Distance Disease-free Survival (DDFS) | distant recurrence From randomization until time of event up to 2 years | Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause. |
Countries
China
Contacts
STUDY_CHAIRZhimin Shao
Fudan University
Outcome results
None listed