HER2 + Breast CancerPhase 2/3NCT07294534
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
A Phase 2/3 study testing HLX87+HX22, HLX87 + Pertuzumab and TCbHP in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech.
Trial summary
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of 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?
- HLX87+HX22, HLX87 + Pertuzumab and TCbHP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2026to 1 Feb 2030
- Phase
- Phase 2/3
- 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
- 1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements; 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Primary breast cancer meeting the following criteria:
- Histologically confirmed invasive breast cancer;
- Clinical stage (assessed by mammography or MRI): T0-4 (including inflammatory breast cancer), N1-3, M0; or ≥ T3, N0, M0 (according to AJCC 8th edition);
- HER2-positive as determined by the central laboratory, defined as IHC 3+ or IHC 2+ and ISH-positive;
- For unifocal and multifocal tumors (i.e., more than one tumor, all confined to the same quadrant as the primary tumor), at least 1 lesion should be sampled and confirmed as HER2-positive by the central laboratory;
- For multi-centric tumors (i.e., multiple tumors involving two or more quadrants of the breast), 1 lesion should be sampled from each affected quadrant and confirmed as HER2-positive by the central laboratory, and all tested quadrants must be confirmed as HER2-positive;
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- Positive or negative for hormone receptors HR (including estrogen receptor [ER] and progesterone receptor [PgR]) as determined by the central laboratory.
- Note: According to ASCO-CAP guidelines, HR-positive is defined as: ER and/or PgR ≥ 1% cells have nuclear staining; HR-negative is defined as: ER < 1% cells have nuclear staining and PR < 1% cells have nuclear staining.
- During the screening period, unstained tumor sections should be provided to the central laboratory for relevant tests according to the laboratory manual.
- 4. Consent for surgery after neoadjuvant therapy. 5. Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO) or multi-gated acquisition (MUGA) scan (within 28 days prior to the first dose).
- 6. No prior systemic anti-tumor treatment for this current breast cancer (including systemic chemotherapy, molecular targeted drug therapy, biological therapy, and other investigational medicinal products).
- 7. ECOG PS score of 0-1 within 7 days prior to the first dose. 8. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). In case of HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 2500 copies/mL or 500 IU/mL or within the reference range of the site.
- 9. HCV antibody (-); subjects with HCV antibody (+) must have a negative HCV-RNA test result to be enrolled. Subjects with HBV/HCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody) 10. HIV antibody (-). 11. Have adequate organ function as defined by the following criteria (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor [CSF] within 14 days prior to the first dose in this study) 12. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to take a medically approved contraceptive measure (e.g., intra-uterine contraceptive device, contraceptive pills, or condoms) during the study treatment period and for at least 7 months after the last dose of study treatment.
Who cannot join
- 1. Past medical history of invasive breast carcinoma. 2. Stage IV (metastatic) breast cancer (per AJCC 8th edition). 3. History of any second malignancy within 3 years prior to signing the ICF, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
- 4. With serious heart disease or medical history, including but not limited to the following conditions:
- Any previous and current heart failure or systolic dysfunction meeting the NYHA criteria;
- High-risk uncontrollable arrhythmia: atrial tachycardia with resting heart rate > 100 beats/min, significant ventricular arrhythmia (such as ventricular tachycardia), or high-grade atrioventricular block (such as Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
- Unstable angina or angina requiring antianginal medication
- History of transmural myocardial infarction shown by ECG
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- Clinically significant cardiac valvular disease;
- Poorly controlled hypertension (with systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg).
- 5. Cerebrovascular accident within 6 months prior to the first dose. 6. Use of immunosuppressants within 14 days prior to the first dose, except for intranasal and inhaled corticosteroids, systemic corticosteroids with a dose of less than 10 mg/day of prednisone/prednisolone or equivalent.
- 7. Active systemic infection requiring intravenous antibiotics, antivirals, or antifungals within 7 days prior to the first dose.
- 8. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids, current presence of pneumonitis/ILD, or suspected pneumonitis/ILD cannot be ruled out by imaging during the screening period.
- 9. Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive pulmonary disease, significant pleural effusion etc.), any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pulmonary resection.
- 10. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose. Note: If the patient is enrolled, live vaccines should not be administered during the study and within 30 days after the last study treatment.
- 12. Participation in other clinical studies within 30 days prior to signing the informed consent form. Unless the clinical study is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- 13. Known history of severe anaphylaxis to macromolecular protein preparations, hypersensitivity to any component in the formulation of the investigational product, or severe hypersensitivity to any excipients of investigational product.
- 14. Have received major surgery within 28 days prior to the first dose. In this study, a major surgery is defined as any surgery which requires at least 3 weeks of postoperative recovery time before receiving the study treatment. Local radiotherapy, radiofrequency ablation, and interventional therapy (excluding previous diagnostic biopsy) within 2 weeks prior to the first dose.
- 15. Known history of abuse of psychotropic drugs or drug addiction. 16. Pregnant or lactating women. 17. Other factors, as determined by the investigator, which may result in premature discontinuation of treatment. For example, other serious medical conditions (including mental illnesses) requiring concomitant treatment, serious laboratory abnormalities, family or social factors, and other conditions that may affect the safety of the subjects or the collection of study data.
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: An Open-Label, Randomized, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87 (HER2 ADC) in Combination With HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) or Pertuzumab vs. TCbHP in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
- Conditions
- HER2 + Breast Cancer
- Being tested
- HLX87+HX22, HLX87 + Pertuzumab, TCbHP
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX87+HX22Drug
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2
HLX87 + PertuzumabDrug
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan.
TCbHPDrug
Docetaxel +Carboplatin+Trastuzumab+Pertuzumab+
| Study group | Role | What they receive |
|---|---|---|
| HLX87+ HLX22 | Experimental | Patients will receive the treatment once every 3 weeks (Q3W), for 8 cycles. Receives: Drug: HLX87+HX22 |
| HLX87+ Pertuzumab | Experimental | Patients will receive the treatment once every 3 weeks (Q3W), for 8 cycles. Receives: Drug: HLX87 + Pertuzumab |
| TCbHP | Active comparator | Patients will receive the treatment once every 3 weeks (Q3W), for 6cycles. Receives: Drug: TCbHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Total pathologic complete response (tpCR) rate
as assessed by the Independent Review Committee (IRC). tpCR is defined as the absence of histological evidence of malignancy in both the primary lesion of breast cancer and regional lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 8th edition).
Measured: up to 24 weeks
Secondary outcomes (4)
• tpCR rate assessed by the study site
Measured: up to 24 weeks
• Breast pathologic complete response (bpCR) rate
Measured: up to 24 weeks
Objective response rate (ORR)
Measured: up to 24 weeks
Incidence and severity of adverse events (AEs)
Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start27 Jan 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion1 Feb 2030 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 817 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiming Shao, Dr, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294534
- Sponsor's protocol ID
- HLX87-BC002
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87 (HER2 ADC) in Combination With HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) or Pertuzumab vs. TCbHP in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07294534
- Acronym / sponsor ID
- HLX87-BC002
- Conditions
- HER2 + Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 817 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 19 Dec 2025 (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.
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HLX87+ HLX22 | Experimental | Drug: HLX87+HX22Patients will receive the treatment once every 3 weeks (Q3W), for 8 cycles. |
| HLX87+ Pertuzumab | Experimental | Drug: HLX87 + PertuzumabPatients will receive the treatment once every 3 weeks (Q3W), for 8 cycles. |
| TCbHP | Active comparator | Drug: TCbHPPatients will receive the treatment once every 3 weeks (Q3W), for 6cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements; 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Primary breast cancer meeting the following criteria:
- Note: According to ASCO-CAP guidelines, HR-positive is defined as: ER and/or PgR ≥ 1% cells have nuclear staining; HR-negative is defined as: ER < 1% cells have nuclear staining and PR < 1% cells have nuclear staining.
- During the screening period, unstained tumor sections should be provided to the central laboratory for relevant tests according to the laboratory manual.
- 4. Consent for surgery after neoadjuvant therapy. 5. Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO) or multi-gated acquisition (MUGA) scan (within 28 days prior to the first dose).
- 6. No prior systemic anti-tumor treatment for this current breast cancer (including systemic chemotherapy, molecular targeted drug therapy, biological therapy, and other investigational medicinal products).
Key exclusion criteria (17 listed)
- 1. Past medical history of invasive breast carcinoma. 2. Stage IV (metastatic) breast cancer (per AJCC 8th edition). 3. History of any second malignancy within 3 years prior to signing the ICF, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
- 4. With serious heart disease or medical history, including but not limited to the following conditions:
- 5. Cerebrovascular accident within 6 months prior to the first dose. 6. Use of immunosuppressants within 14 days prior to the first dose, except for intranasal and inhaled corticosteroids, systemic corticosteroids with a dose of less than 10 mg/day of prednisone/prednisolone or equivalent.
- 7. Active systemic infection requiring intravenous antibiotics, antivirals, or antifungals within 7 days prior to the first dose.
- 8. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids, current presence of pneumonitis/ILD, or suspected pneumonitis/ILD cannot be ruled out by imaging during the screening period.
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 |
|---|---|---|
| HLX87+HX22HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 | Drug | HLX87+ HLX22 |
| HLX87 + PertuzumabHLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. | Drug | HLX87+ Pertuzumab |
| TCbHPDocetaxel +Carboplatin+Trastuzumab+Pertuzumab+ | Drug | TCbHP |
Primary outcome
• Total pathologic complete response (tpCR) rate
Time frame: up to 24 weeks
as assessed by the Independent Review Committee (IRC). tpCR is defined as the absence of histological evidence of malignancy in both the primary lesion of breast cancer and regional lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 8th edition).
4 secondary outcomes
• tpCR rate assessed by the study site
Time frame: up to 24 weeks
• Breast pathologic complete response (bpCR) rate
Time frame: up to 24 weeks
Objective response rate (ORR)
Time frame: up to 24 weeks
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 60 months
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 19 Dec 2025.
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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.
Zhiming Shao, Dr principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HLX87+HX22, HLX87 + Pertuzumab and TCbHP 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 13 inclusion and 17 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 19 Dec 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Even Yi, Dr (021-33395800, Yiwen_YI@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Total pathologic complete response (tpCR) rate (time frame: up to 24 weeks). 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 19 Dec 2025.