HER2 + Breast CancerPhase 1NCT07601620
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 Phase 1 study testing HLX319 and EU-Phesgo® in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 + Breast Cancer
- What is being tested?
- HLX319 and EU-Phesgo®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2026to 22 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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 .
Read the detailed description
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.
- Conditions
- HER2 + Breast Cancer
- Being tested
- HLX319, EU-Phesgo®
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX319Drug
HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)
EU-Phesgo®Drug
EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)
| Study group | Role | What they receive |
|---|---|---|
| HLX319 | Experimental | The regimen in the experimental group is HLX319 in combination with docetaxel and carboplatin. Receives: Drug: HLX319 |
| EU-Phesgo® | Active comparator | The regimen in the control group is EU-Phesgo® in combination with docetaxel and carboplatin. Receives: Drug: EU-Phesgo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Peak concentration after a single drug administration in Cycle 1.
Measured: 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.
Measured: up to 180 days
Steady-state peak concentration (Cmax,ss)
The steady-state peak concentration after multiple doses administration in Cycle 4.
Measured: 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.
Measured: up to 180 days
Secondary outcomes (26)
Trough concentration (Ctrough)
Trough concentration after a single dose administration
Measured: up to 180 days
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
Measured: up to 180 days
Percentage of extrapolated area in the total AUC (%AUCex)
Percentage of extrapolated area in the total AUC after a single dose administration
Measured: up to 180 days
Time to peak concentration (Tmax)
time to peak concentration after a single dose administration
Measured: up to 180 days
Elimination half-life (T1/2)
elimination half-life after a single dose administration
Measured: up to 180 days
Total clearance (CL/F)
total clearance after a single dose administration
Measured: up to 180 days
Terminal phase distribution volume (Vz/F)
terminal phase distribution volume after a single dose administration
Measured: up to 180 days
Mean residence time (MRT)
mean residence time after a single dose administration
Measured: up to 180 days
Steady-state trough concentration (Ctrough,ss)
steady-state trough concentration after multiple doses administration in Cycle 4
Measured: up to 180 days
Average steady-state concentration (Caverage,ss)
average steady-state concentration after multiple doses administration in Cycle 4
Measured: up to 180 days
Steady-state time to peak concentration (Tmax,ss)
steady-state time to peak concentration after multiple doses administration in Cycle 4
Measured: up to 180 days
Elimination half-life (T1/2,ss)
elimination half-life after multiple doses administration in Cycle 4
Measured: up to 180 days
Steady-state volume of distribution (Vss/F)
steady-state volume of distribution after multiple doses administration in Cycle 4
Measured: up to 180 days
Steady-state total clearance (CLss/F)
steady-state total clearance after multiple doses administration in Cycle 4
Measured: up to 180 days
accumulation ratio based on Cmax (RCmax)
accumulation ratio based on Cmax after multiple doses administration in Cycle 4
Measured: up to 180 days
Accumulation ratio based on AUC (RAUC)
accumulation ratio based on AUC after multiple doses administration in Cycle 4
Measured: up to 180 days
The total pathological complete response (tpCR) rate assessed by the investigator
Measured: up to 180 days
Breast pathologic complete response (bpCR) rate assessed by the investigator
Measured: up to 180 days
Objective response rate (ORR) assessed by the investigator
according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: up to 180 days
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0
Measured: up to 180 days
Number of participants with abnormal vital signs
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: up to 180 days
Number of participants with abnormal physical examination findings
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: up to 180 days
Number of participants with abnormal Laboratory tests results
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: up to 180 days
Number of participants with abnormal 12-lead ECG readings
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: up to 180 days
Positivity rates of anti-drug antibodies (ADA)
Measured: up to 180 days
Positivity rates of neutralizing antibodies (NAb)
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start3 Jul 2026 (estimated)
- Primary completion23 Apr 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 + Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601620
- Sponsor's protocol ID
- HLX319-BC001
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601620
- Acronym / sponsor ID
- HLX319-BC001
- Conditions
- HER2 + Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2026 (estimated)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX319 | Experimental | Drug: HLX319The regimen in the experimental group is HLX319 in combination with docetaxel and carboplatin. |
| EU-Phesgo® | Active comparator | Drug: EU-Phesgo®The regimen in the control group is EU-Phesgo® in combination with docetaxel and carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX319HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection) | Drug | HLX319 |
| EU-Phesgo®EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection) | Drug | EU-Phesgo® |
Primary outcome
Peak concentration (Cmax)
Time frame: up to 180 days
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)
Time frame: 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.
Steady-state peak concentration (Cmax,ss)
Time frame: up to 180 days
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)
Time frame: 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.
26 secondary outcomes
Trough concentration (Ctrough)
Time frame: up to 180 days
Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: up to 180 days
Percentage of extrapolated area in the total AUC (%AUCex)
Time frame: up to 180 days
Time to peak concentration (Tmax)
Time frame: up to 180 days
Elimination half-life (T1/2)
Time frame: up to 180 days
Total clearance (CL/F)
Time frame: up to 180 days
Terminal phase distribution volume (Vz/F)
Time frame: up to 180 days
Mean residence time (MRT)
Time frame: up to 180 days
Steady-state trough concentration (Ctrough,ss)
Time frame: up to 180 days
Average steady-state concentration (Caverage,ss)
Time frame: up to 180 days
Steady-state time to peak concentration (Tmax,ss)
Time frame: up to 180 days
Elimination half-life (T1/2,ss)
Time frame: up to 180 days
Steady-state volume of distribution (Vss/F)
Time frame: up to 180 days
Steady-state total clearance (CLss/F)
Time frame: up to 180 days
accumulation ratio based on Cmax (RCmax)
Time frame: up to 180 days
Accumulation ratio based on AUC (RAUC)
Time frame: up to 180 days
The total pathological complete response (tpCR) rate assessed by the investigator
Time frame: up to 180 days
Breast pathologic complete response (bpCR) rate assessed by the investigator
Time frame: up to 180 days
Objective response rate (ORR) assessed by the investigator
Time frame: up to 180 days
Incidence and severity of adverse events (AEs)
Time frame: up to 180 days
Number of participants with abnormal vital signs
Time frame: up to 180 days
Number of participants with abnormal physical examination findings
Time frame: up to 180 days
Number of participants with abnormal Laboratory tests results
Time frame: up to 180 days
Number of participants with abnormal 12-lead ECG readings
Time frame: up to 180 days
Positivity rates of anti-drug antibodies (ADA)
Time frame: up to 180 days
Positivity rates of neutralizing antibodies (NAb)
Time frame: up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX319 and EU-Phesgo® in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Jin (86 159 5516 0489, Qi_jin@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: up to 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.