> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-pharmacokinetics-efficacy-and-safety-4a053155-4202-47ae-8b8a-a183cdaa6594 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) Participants 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) Start date 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Title and summary **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 . Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Official title** A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Dates **Completion date** 2027-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **First posted** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Primary completion date** 2027-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Start date** 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Size and sites **Participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Planned participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Identifiers **Registry ID** NCT07601620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **ClinicalTrials.gov ID** NCT07601620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Outcomes ### Primary outcomes 1. Peak concentration (Cmax) Timeframe: up to 180 days Peak concentration after a single drug administration in Cycle 1. 2. Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d) Timeframe: up to 180 days Area under the serum drug concentration-time curve from 0 to 21 days after a single drug administration in Cycle 1. 3. Steady-state peak concentration (Cmax,ss) Timeframe: up to 180 days The steady-state peak concentration after multiple doses administration in Cycle 4. 4. Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss) Timeframe: up to 180 days Steady-state area under the serum drug concentration-time curve within a dosing interval after multiple doses administration in Cycle 4. ### Secondary outcomes 1. Trough concentration (Ctrough) Timeframe: up to 180 days Trough concentration after a single dose administration 2. Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf) Timeframe: up to 180 days Area under the serum drug concentration-time curve from time 0 to infinity after a single dose administration 3. Percentage of extrapolated area in the total AUC (%AUCex) Timeframe: up to 180 days Percentage of extrapolated area in the total AUC after a single dose administration 4. Time to peak concentration (Tmax) Timeframe: up to 180 days time to peak concentration after a single dose administration 5. Elimination half-life (T1/2) Timeframe: up to 180 days elimination half-life after a single dose administration 6. Total clearance (CL/F) Timeframe: up to 180 days total clearance after a single dose administration 7. Terminal phase distribution volume (Vz/F) Timeframe: up to 180 days terminal phase distribution volume after a single dose administration 8. Mean residence time (MRT) Timeframe: up to 180 days mean residence time after a single dose administration 9. Steady-state trough concentration (Ctrough,ss) Timeframe: up to 180 days steady-state trough concentration after multiple doses administration in Cycle 4 10. Average steady-state concentration (Caverage,ss) Timeframe: up to 180 days average steady-state concentration after multiple doses administration in Cycle 4 11. Steady-state time to peak concentration (Tmax,ss) Timeframe: up to 180 days steady-state time to peak concentration after multiple doses administration in Cycle 4 12. Elimination half-life (T1/2,ss) Timeframe: up to 180 days elimination half-life after multiple doses administration in Cycle 4 13. Steady-state volume of distribution (Vss/F) Timeframe: up to 180 days steady-state volume of distribution after multiple doses administration in Cycle 4 14. Steady-state total clearance (CLss/F) Timeframe: up to 180 days steady-state total clearance after multiple doses administration in Cycle 4 15. accumulation ratio based on Cmax (RCmax) Timeframe: up to 180 days accumulation ratio based on Cmax after multiple doses administration in Cycle 4 16. Accumulation ratio based on AUC (RAUC) Timeframe: up to 180 days accumulation ratio based on AUC after multiple doses administration in Cycle 4 17. The total pathological complete response (tpCR) rate assessed by the investigator Timeframe: up to 180 days 18. Breast pathologic complete response (bpCR) rate assessed by the investigator Timeframe: up to 180 days 19. Objective response rate (ORR) assessed by the investigator Timeframe: up to 180 days according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria 20. Incidence and severity of adverse events (AEs) Timeframe: up to 180 days severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0 21. Number of participants with abnormal vital signs Timeframe: up to 180 days Detailed Outcome Measure will be defined in the Statistical Analysis Plan 22. Number of participants with abnormal physical examination findings Timeframe: up to 180 days Detailed Outcome Measure will be defined in the Statistical Analysis Plan 23. Number of participants with abnormal Laboratory tests results Timeframe: up to 180 days Detailed Outcome Measure will be defined in the Statistical Analysis Plan 24. Number of participants with abnormal 12-lead ECG readings Timeframe: up to 180 days Detailed Outcome Measure will be defined in the Statistical Analysis Plan 25. Positivity rates of anti-drug antibodies (ADA) Timeframe: up to 180 days And 1 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07601620) ## Related records ### Drugs (2) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (1) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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