HER2 + Breast CancerPhase 2/3NCT07294508
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
A Phase 2/3 study testing HLX87 + HLX22, HLX87 + Pertuzumab and T-Dxd + Pertuzumab in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic 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 + HLX22, HLX87 + Pertuzumab and T-Dxd + Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2026to 30 Dec 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, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:
- Advanced or metastatic breast cancer.
- HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
- Positive or negative for hormone receptor HR (including estrogen receptor [ER] and progesterone receptor [PgR]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).
- 5. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.
- 7. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.
- 8. Life expectancy ≥ 12 weeks. 9. Adequate organ functions
Who cannot join
- 1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).
- 3. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
- 4. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.
- 6. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .
- 7. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
- 9. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).
Show all 9Show fewer
- 10. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.
- 12. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.
- 13. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma, Dr, 86-010-87788888, Feima2011@169.com
About this study
Official title: An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
Read the detailed description
The study consists of two stages Stage I is an open-label, multicenter, randomized, parallel-controlled phase II clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on ORR and PFS results.
Stage II is an open-label, multicenter, randomized, parallel-controlled phase III clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on PFS results.
- Conditions
- HER2 + Breast Cancer
- Being tested
- HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab, THP
- 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 + HLX22Drug
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
T-Dxd + PertuzumabDrug
T-Dxd is a HER2-targeted ADC
THPDrug
Pertuzumab+ Trastuzumab+Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| HLX87+ HLX22 | Experimental | Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). Receives: Drug: HLX87 + HLX22 |
| HLX87+ Pertuzumab | Experimental | atients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). Receives: Drug: HLX87 + Pertuzumab |
| T-Dxd + Pertuzumab | Active comparator | Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). Receives: Drug: T-Dxd + Pertuzumab |
| THP | Active comparator | Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). Receives: Drug: THP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)
Measured: up to 26 months
Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)
Measured: up to 37 months
Secondary outcomes (5)
● ORR (assessed by the investigator as per RECIST v1.1)
Measured: up to 26 months
● PFS (assessed by the investigator as per RECIST v1.1)
Measured: up to 37 months
Second progression-free survival (PFS2)
Measured: up to 37 months
Overall survival (OS)
Measured: up to 37 months
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 37 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 Feb 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion30 Dec 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
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Ma, Dr, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294508
- Sponsor's protocol ID
- HLX87-BC001
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 20 Mar 2026
- 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 20 Mar 2026. 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 HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07294508
- Acronym / sponsor ID
- HLX87-BC001
- Conditions
- HER2 + Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 30 Dec 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 HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
Detailed description
The study consists of two stages Stage I is an open-label, multicenter, randomized, parallel-controlled phase II clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on ORR and PFS results.
Stage II is an open-label, multicenter, randomized, parallel-controlled phase III clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on PFS results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX87+ HLX22 | Experimental | Drug: HLX87 + HLX22Patients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). |
| HLX87+ Pertuzumab | Experimental | Drug: HLX87 + Pertuzumabatients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). |
| T-Dxd + Pertuzumab | Active comparator | Drug: T-Dxd + PertuzumabPatients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). |
| THP | Active comparator | Drug: THPPatients will receive the treatment once every 3 weeks (Q3W) until progressive disease (PD) , initiation of new anti-tumor therapy, death, intolerable toxicity, withdrawal of informed consent, or end of the study (whichever occurs first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:
- 5. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.
- 7. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.
- 8. Life expectancy ≥ 12 weeks. 9. Adequate organ functions
Key exclusion criteria (9 listed)
- 1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).
- 3. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
- 4. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.
- 6. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .
- 7. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
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 + HLX22HLX87 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 |
| T-Dxd + PertuzumabT-Dxd is a HER2-targeted ADC | Drug | T-Dxd + Pertuzumab |
| THPPertuzumab+ Trastuzumab+Docetaxel | Drug | THP |
Primary outcome
Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)
Time frame: up to 26 months
Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)
Time frame: up to 37 months
5 secondary outcomes
● ORR (assessed by the investigator as per RECIST v1.1)
Time frame: up to 26 months
● PFS (assessed by the investigator as per RECIST v1.1)
Time frame: up to 37 months
Second progression-free survival (PFS2)
Time frame: up to 37 months
Overall survival (OS)
Time frame: up to 37 months
Incidence and severity of adverse events (AEs)
Time frame: up to 37 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 20 Mar 2026.
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Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
Fei Ma, Dr principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HLX87 + HLX22, HLX87 + Pertuzumab and T-Dxd + Pertuzumab in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech at 1 site in China.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Maoqing Fu, Dr (021-33395800, Maoqing_fu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1) (time frame: up to 26 months). The study lists 2 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 20 Mar 2026.