Overview

A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

Status:
Active, not recruiting
Trial end date:
2024-07-31
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
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.