Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

Breast Cancer Invasive Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910398
• Other study ID #: LY2023-063-A
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: August 2030

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Wenjin Yin, M.D.
• Phone: 86(21)58852345
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: August 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms

Intervention

Drug:
• pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

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.	From randomization until time of event up to 2 years
Secondary	Adverse events	Adverse events will be assessed according to the NCI CTCAE v5.0.	From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)