Treatment for HER2-positive recurrent or metastatic breast cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged =18 years and <80 years. 2. Patients diagnosed with recurrent or metastatic breast cancer as HER2-positive by pathology testing (HER2-positive is defined as an immunohistochemistry (IHC) score of 3+ or 2+ for HER2 and a positive in-situ hybridization (ISH) test confirmed by a pathology laboratory). 3. Have received at least two lines of pyrotinib-containing regimens in advanced stages. 4. Have at least 2 months or more of follow-up data from the initiation of the pyrotinib-containing regimen to the point of data collection. 5. Presence of a measurable lesion as defined by the revised Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). 6. Adequate hematologic, hepatic, and renal functions.
Exclusion criteria
Exclusion criteria: 1. Pyrotinib medication use as neoadjuvant therapy. 2. Severe adverse side effects could not be controlled by dose reductions according to drug instructions. 3. Loss to follow-up for other unknown reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) on the first pyrotinib treatment and PFS on re-treatment with pyrotinib) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. OS (overall survival) 2. ORR (objective response rate assessed by RECIST 1.1) 3. CBR (clinical benefit rate assessed by RECIST 1.1) | — |
Countries
China