This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.
Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Trastuzumab Rezetecan
Pertuzumab
pCR rate
Total pathological complete response (tpCR: ypT0-is,ypN0)
Time frame: At the time of surgery
iDFS
Invasive disease-free survival
Time frame: Up to approximately 5 years
EFS
Event-free survival
Time frame: Up to approximately 5 years
ORR
Objective Response Rate
Time frame: Up to approximately 24 weeks after the first administration
AEs
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE 5.0
Time frame: From the first dose until 30 days after last dose
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