Continuous versus intermittent pyrotinib for HER2-positive advanced 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 is a prospective, randomized, controlled, multicenter phase 2 trial comparing continuous and intermittent dosing schedules of pyrotinib in patients with HER2-positive advanced or locally advanced breast cancer. Eligible adults have pathologically confirmed HER2-positive disease, measurable lesions or bone-only disease per RECIST v1.1, ECOG 0-1, and adequate organ function, and may have received any number of prior therapies for advanced disease. Participants are randomized to receive either continuous or intermittent pyrotinib and will be followed for measures of tumor response and safety using standard clinical criteria. Pregnancy, lactation, and difficulties with drug administration or absorption are exclusion criteria and treatment is managed per protocol and physician discretion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥18 years old
* Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
* Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
* Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
* ECOG 0-1
* Adequate organ function

Exclusion Criteria:

* During pregnancy and lactation
* Difficulties with pyrotinib administration or absorption

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 Jiaotong University
• Study coordinator: Wenjin Yin, M.D.
• Email: yinwenjin@renji.com
• Phone: 86(21)68385569

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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.