This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).
Male or female aged ≥ 18 years old at the time of signing the ICF;
Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.
Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.
Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.
History of other malignancy within 5 years.
Prior systemic therapy for breast cancer treatment or radiotherapy.
Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.
Parallel
HLX319
DrugHLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)
EU-Phesgo®
DrugEU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)
Peak concentration (Cmax)
Peak concentration after a single drug administration in Cycle 1.
Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d)
Area under the serum drug concentration-time curve from 0 to 21 days after a single drug administration in Cycle 1.
Steady-state peak concentration (Cmax,ss)
The steady-state peak concentration after multiple doses administration in Cycle 4.
Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss)
Steady-state area under the serum drug concentration-time curve within a dosing interval after multiple doses administration in Cycle 4.
Trough concentration (Ctrough)
Trough concentration after a single dose administration
Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)
Area under the serum drug concentration-time curve from time 0 to infinity after a single dose administration
Percentage of extrapolated area in the total AUC (%AUCex)
Percentage of extrapolated area in the total AUC after a single dose administration
Time to peak concentration (Tmax)
time to peak concentration after a single dose administration
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