Back to resultsA Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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.
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm Pyrotinib
Arm Placebo
Arm Description
Intervention: Drug: Pyrotinib
Intervention: Drug: Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
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.
Full Information
NCT ID
NCT03980054
First Posted
June 6, 2019
Last Updated
May 20, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03980054
Brief Title
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pyrotinib versus Placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Pyrotinib
Arm Type
Experimental
Arm Description
Intervention: Drug: Pyrotinib
Arm Title
Arm Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Drug: Placebo
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
pyrotinib 400 mg, orally once daily for one year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 400mg, orally once daily for one year
Primary Outcome Measure Information:
Title
Invasive Disease-free Survival (iDFS)
Description
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.
Time Frame
From randomization until time of event up to 2 years
Secondary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
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.
Time Frame
From randomization until time of event up to 2 years
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from randomization to death from any cause.
Time Frame
up to 2 years
Title
Distance Disease-free Survival (DDFS)
Description
Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.
Time Frame
distant recurrence From randomization until time of event up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
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