This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.
The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.
Study Type
OBSERVATIONAL
Enrollment
42
240\~320mg given by mouth (orally) once daily every 21days
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
420mg given by IV every 21 days
Progression-free survival (PFS)
The time from the patient begins treatment to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Time frame: Up to approximately 3 years
Overall survival (OS)
The time from the date the patient begins treatment to death from any cause.
Time frame: Up to approximately 5 years
Central nervous system (CNS) PFS
The time from the patient begins treatment to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause
Time frame: Up to approximately 3 years
Incidence of adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of adverse events
Time frame: Start of treatment until 3-year follow-up
Incidence of serious adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of serious adverse events
Time frame: Start of treatment until 3-year follow-up
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600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.