Continuous versus intermittent pyrotinib for HER2-positive advanced breast cancer
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
This tests whether taking pyrotinib continuously or on an intermittent schedule works better and is safer for adults with HER2-positive advanced breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | pyrotinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07180082 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed HER2-positive advanced or locally advanced breast cancer not amenable to curative surgery, measurable disease or bone-only disease, ECOG 0-1, adequate organ function, and deemed appropriate for pyrotinib by their physician are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, who have difficulty taking or absorbing pyrotinib, who have poor performance status (ECOG >1), or who do not have HER2-positive disease are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the trial could identify a dosing schedule that preserves pyrotinib's anti-cancer effects while reducing side effects and treatment burden.
How similar studies have performed: Pyrotinib has demonstrated activity in prior trials for HER2-positive advanced breast cancer, but direct comparisons of continuous versus intermittent dosing schedules have been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Jiaotong University
- Study coordinator: Wenjin Yin, M.D.
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.