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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: yinwenjin@renji.com
• Phone: 86(21)58852345

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

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  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.