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.
Age ≥ 18 years, male or female.
Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification), with known HR status.
Have unresectable locally advanced or metastatic disease. If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
Other malignancy diagnosed within 5 years prior to enrollment.
Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib.
Patients who are difficult or unable to be followed-up.
Other reasons that, in the investigator's judgment, make the patient unsuitable for participation in this study.
The study population consists of adult patients (age ≥18) with HER2-positive advanced breast cancer who have completed 4-8 cycles of first-line induction therapy with trastuzumab, pertuzumab, and chemotherapy without disease progression. Participants will be recruited from the Department of Breast Oncology at Peking University Cancer Hospital and will be enrolled consecutively after meeting all eligibility criteria and providing informed consent.
Cohort
Prospective
Pyrotinib
Drug240\~320mg given by mouth (orally) once daily every 21days
Trastuzuma
Drug6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Pertuzumab
Drug420mg given by IV every 21 days
Combination product: Trastuzumab + Pertuzumab
Drug600 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.
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
Overall survival (OS)
The time from the date the patient begins treatment to death from any cause.
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
Incidence of adverse events
Severity of adverse events
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