Advanced Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGPyrotinib
anti-HER2 tyrosine kinase inhibitor
Sponsors
Wenjin Yin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) | PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first. |
| Adverse events | From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year) | Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Backup ContactYin
Outcome results
None listed