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.