Back to resultsContinuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer (CORINNE-PI)
Primary Purpose
Breast Cancer Invasive
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Invasive
Eligibility Criteria
Inclusion Criteria: Aged ≥18 and ≤70 years; Histologically confirmed invasive HER2 positive breast cancer; Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Adequate organ functions. Exclusion Criteria: Metastatic disease (Stage IV); Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; Treated or treating with anti-HER2 tyrosine kinase inhibitor; Less than 4 weeks from the last clinical trial; History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
continuous pyrotinib
intermittent pyrotinib
Arm Description
pyrotinib 400 mg, orally once daily for one year
pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles
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.
Adverse events
Adverse events will be assessed according to the NCI CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05910398
Brief Title
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Acronym
CORINNE-PI
Official Title
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
April 2030 (Anticipated)
Study Completion Date
August 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
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 prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Invasive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
488 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuous pyrotinib
Arm Type
Active Comparator
Arm Description
pyrotinib 400 mg, orally once daily for one year
Arm Title
intermittent pyrotinib
Arm Type
Experimental
Arm Description
pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles
Intervention Type
Drug
Intervention Name(s)
pyrotinib
Intervention Description
an irreversible anti-HER2 tyrosine kinase inhibitor
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
From randomization until time of event up to 2 years
Title
Adverse events
Description
Adverse events will be assessed according to the NCI CTCAE v5.0.
Time Frame
From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥18 and ≤70 years;
Histologically confirmed invasive HER2 positive breast cancer;
Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
Adequate organ functions.
Exclusion Criteria:
Metastatic disease (Stage IV);
Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
Treated or treating with anti-HER2 tyrosine kinase inhibitor;
Less than 4 weeks from the last clinical trial;
History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjin Yin, M.D.
Phone
86(21)58852345
Email
yinwenjin@renji.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Lu
Phone
86(21)68383364
Email
rjllb3364@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjin Yin, M.D.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
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