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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Overall response rate (ORR) — From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years) ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiaotong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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