Clareo Health | A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a randomized, double-blind, parallel-controlled, multi-center Phase I equivalence study to compare the similarity in PK profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer with a primary tumor \> 2 cm or nodes-positive.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.
An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
Adequate major organ functions.
Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.
You may not be if
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.
Patients who have undergone excision biopsy of the primary tumor and/or axillary lymph nodes or lymph node dissection.
Have severe heart disease or medical conditions.
Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.
Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.
Daily use of corticosteroid treatment is required.
Sensitivity to any study medications or any of its ingredients or excipients.
Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.
Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.
Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.
Any other conditions which are inappropriate for the study in the opinion of the investigator.
