Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer (CORINNE-PI)

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer Invasive

Treatments: Drug: pyrotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05910398

LY2023-063-A

Details and patient eligibility

About

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.

Enrollment: 488 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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488 participants in 2 patient groups

continuous pyrotinib

Active Comparator group

Description:

pyrotinib 400 mg, orally once daily for one year

Treatment:

Drug: pyrotinib

intermittent pyrotinib

Experimental group

Description:

pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles

Treatment:

Drug: pyrotinib