Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Recruiting · NCT07180082 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Renji Hospital, School of Medicine, Shanghai Jiaotong University - Shanghai, China