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

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Placebo; Drug: Pyrotinib

• Registration Number: NCT03980054
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Study Start: 2019-07-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24
• Primary Completion: 2022-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Placebo	Placebo	Intervention: Drug: Placebo
Arm Pyrotinib	Pyrotinib	Intervention: Drug: Pyrotinib

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 2 years	Overall survival is defined as the time from randomization to death from any cause.
Disease-free Survival (DFS)	From randomization until time of event up to 2 years	Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause.
Distance Disease-free Survival (DDFS)	distant recurrence From randomization until time of event up to 2 years	Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China