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

NCT07601620 | Not Yet Recruiting Phase 1

• 1 other identifier: HLX319-BC001
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

HER2 + Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Peak concentration (Cmax)

  Peak concentration after a single drug administration in Cycle 1.

  up to 180 days

• 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.

  up to 180 days

• Steady-state peak concentration (Cmax,ss)

  The steady-state peak concentration after multiple doses administration in Cycle 4.

  up to 180 days

• 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.

  up to 180 days

Secondary Outcomes (26)

• Trough concentration (Ctrough)

  up to 180 days

• Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)

  up to 180 days

• Percentage of extrapolated area in the total AUC (%AUCex)

  up to 180 days

• Time to peak concentration (Tmax)

  up to 180 days

• Elimination half-life (T1/2)

  up to 180 days

Study Arms (2)

HLX319

EXPERIMENTAL

The regimen in the experimental group is HLX319 in combination with docetaxel and carboplatin.

Drug: HLX319

EU-Phesgo®

ACTIVE COMPARATOR

The regimen in the control group is EU-Phesgo® in combination with docetaxel and carboplatin.

Drug: EU-Phesgo®

Interventions

HLX319 DRUG

HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)

HLX319

EU-Phesgo® DRUG

EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)

EU-Phesgo®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Qi Jin

CONTACT

86 159 5516 0489; Qi_jin@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 3, 2026
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05