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

Hengrui Medicine

Status and phase

Active, not recruiting

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Pyrotinib

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03980054

HR-BLTN-III-EBC

Details and patient eligibility

About

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.

Enrollment

1,192 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.