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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Invasive
• Intervention / Treatment: Drug: pyrotinib

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qi Lu; Phone Number: 86(21)68383364; Email: rjllb3364@163.com
• Study Contact Backup: Name: Wenjin Yin, M.D.; Phone Number: 86(21)58852345; Email: yinwenjin@renji.com

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    • Contact: Wenjin Yin; Phone Number: 86(21)68385569; Email: yinwenjin@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continuous pyrotinib; pyrotinib 400 mg, orally once daily for one year	Drug: pyrotinib; an irreversible anti-HER2 tyrosine kinase inhibitor
Experimental: intermittent pyrotinib; pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles	Drug: pyrotinib; an irreversible anti-HER2 tyrosine kinase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Wenjin Yin, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; pyrotinib
• Other Study ID Numbers: LY2023-063-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No