Comparing continuous and intermittent use of pyrotinib for HER2-positive breast cancer

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 study is testing whether taking the cancer drug pyrotinib continuously or in intervals helps people with HER2-positive breast cancer do better and feel less side effects after their initial treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 488 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (other)
• Drugs / interventions: trastuzumab, pyrotinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT05910398 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, controlled, multicenter study designed to evaluate the efficacy and safety of continuous versus intermittent extension of adjuvant pyrotinib in patients with invasive HER2-positive breast cancer. Participants will be randomly assigned to receive either continuous or intermittent treatment with pyrotinib after their initial therapy. The study aims to determine which treatment approach provides better outcomes for patients in terms of cancer control and side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with histologically confirmed invasive HER2-positive breast cancer who have completed prior HER2-targeted therapies within the last three years.

Not a fit: Patients with metastatic disease, significant residual cancer after surgery, or those with gastrointestinal absorption issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing treatment strategies for HER2-positive breast cancer, potentially improving patient outcomes.

How similar studies have performed: While there have been studies on HER2-targeted therapies, this specific comparison of continuous versus intermittent pyrotinib use is a novel approach.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Wenjin Yin, M.D. — Renji Hospital, School of Medicine, Shanghai Jiao Tong University
• Study coordinator: Wenjin Yin, M.D.

Conditions: Breast Cancer Invasive