A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
Overview
- Phase
- Phase 3
- Intervention
- Pyrotinib
- Conditions
- Breast Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 1192
- Locations
- 1
- Primary Endpoint
- Invasive Disease-free Survival (iDFS)
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Arm Pyrotinib
Intervention: Drug: Pyrotinib
Intervention: Pyrotinib
Arm Placebo
Intervention: Drug: Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Invasive Disease-free Survival (iDFS)
Time Frame: 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 Outcomes
- Overall Survival (OS)(up to 2 years)
- Disease-free Survival (DFS)(From randomization until time of event up to 2 years)
- Distance Disease-free Survival (DDFS)(distant recurrence From randomization until time of event up to 2 years)