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

NCT05910398 | Recruiting Phase 3 DMC

• 1 other identifier: LY2023-063-A
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Disease-free Survival (DFS)

  From randomization until time of event up to 2 years

• Overall Survival (OS)

  From randomization until time of event up to 2 years

• Adverse events

  From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)

Study Arms (2)

continuous pyrotinib

ACTIVE COMPARATOR

pyrotinib 400 mg, orally once daily for one year

Drug: pyrotinib

intermittent pyrotinib

EXPERIMENTAL

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

Drug: pyrotinib

Interventions

pyrotinib DRUG

an irreversible anti-HER2 tyrosine kinase inhibitor

continuous pyrotinib; intermittent pyrotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)58852345; yinwenjin@renji.com

Qi Lu

CONTACT

86(21)68383364; rjllb3364@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)