Breast Cancer
Conditions
Brief summary
In China, pyrotinib is used for patients with HER2-positive advanced breast cancer who have progressed on trastuzumab. As anti-HER2 antibody therapy has advanced from trastuzumab monotherapy to trastuzumab-pertuzumab dual-target treatment, few clinical studies have investigated pyrotinib's efficacy among patients pre-treated with this dual-antibody regimen. This is a retrospective observational cohort study, which aims to assess the efficacy and safety of pyrotinib in this patient cohort.
Interventions
DRUGPyrotinib 400mg
Pyrotinib (400 mg daily)-based treatment
Sponsors
Beijing 302 Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Diagnosis of unresectable locally advanced or metastatic breast cancer 2. Confirmed HER2-positive status, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization (ISH) results 3. Prior systemic treatment of trastuzumab and pertuzumab 4. Adequate baseline cardiac, bone marrow, renal, hepatic, and blood coagulation functions 5. Life expectancy \> 3 months 6. ECOG ≤3
Exclusion criteria
* 1\. Incomplete clinical case data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | 4 years | PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 1year | ORR was defined as the proportion of patients with a complete response or a partial response |
Countries
China
Contacts
STUDY_DIRECTORTao Wang
Beijing 302 Hospital
Outcome results
None listed