Overview
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2024-07-31
2024-07-31
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.Treatments:
Trastuzumab
Criteria
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.