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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03980054
• Other study ID #: HR-BLTN-III-EBC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 12, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1192
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib
pyrotinib 400 mg, orally once daily for one year
• Placebo
placebo 400mg, orally once daily for one year

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-free Survival (iDFS)	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.	From randomization until time of event up to 2 years
Secondary	Disease-free Survival (DFS)	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.	From randomization until time of event up to 2 years
Secondary	Overall Survival (OS)	Overall survival is defined as the time from randomization to death from any cause.	up to 2 years
Secondary	Distance Disease-free Survival (DDFS)	Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.	distant recurrence From randomization until time of event up to 2 years