Pyrotinib: pyrotinib 400 mg, orally once daily for one year
Placebo: placebo 400mg, orally once daily for one year
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Fudan University Cancer Hospital
Shanghai
China
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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