HER2 + Breast CancerPhase 2NCT07824869
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
A Phase 2 study testing HLX22, Trastuzumab and Capecitabine in people with HER2 + Breast Cancer, run by Shanghai Henlius Biotech.
Trial summary
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. 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?
- HLX22, Trastuzumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 4 Dec 2029
- Phase
- Phase 2
- 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
- Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
- Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
- HER2 positive confirmed by central laboratory.
- Hormone receptor (HR) status confirmed by local laboratory.
- Patients who have progressed after treatment containing within HER2 ADC
- Presence of at least one measurable lesion according to the RECIST v1.1.
- Adequate organ function
Who cannot join
- History of any other malignancy within 2 years prior to signing the ICF.
- Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m2.
- Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
- Uncontrolled or severe cardiovascular disease.
- History of cerebrovascular accident within 6 months prior to randomization.
- Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
Show all 12Show fewer
- Active infection.
- Active tuberculosis.
- Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
- Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
- Pregnant or lactating women or women who plan to become pregnant during the study period.
- History of immunodeficiency or history of organ transplantation.
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, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Read the detailed description
Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).
- Conditions
- HER2 + Breast Cancer
- Being tested
- HLX22, Trastuzumab, Capecitabine, Paclitaxel, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX22Drug
15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W
TrastuzumabDrug
Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.
CapecitabineDrug
1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W
PaclitaxelDrug
175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV
DocetaxelDrug
75-100 mg/m2, D1, Q3W, IV
EribulinDrug
1.4 mg/m2, D1 and D8, Q3W, IV
VinorelbineDrug
25-30 mg/m2, D1 and D8, Q3W, IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | HLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine) Receives: Drug: HLX22; Drug: Trastuzumab; Drug: Capecitabine; Drug: Paclitaxel; Drug: Docetaxel; Drug: Eribulin; Drug: Vinorelbine |
| Control group | Placebo comparator | placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine) Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Paclitaxel; Drug: Docetaxel; Drug: Eribulin; Drug: Vinorelbine |
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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1
Measured: Up to 2 years
Secondary outcomes (6)
Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: up to 5 years
ORR assessed by the investigator as per RECIST 1.1
Measured: up to 2 years
PFS assessed by the investigator as per RECIST 1.1
Measured: up to 5 years
Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1
DoR is defined as the time from the date of first achievement of CR or PR (whichever is documented first) to the date of the first documentation of PD or death (whichever occurs first)
Measured: up to 2 years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: up to 5 years
Adverse Events (AEs)
Incidence and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion4 Dec 2029 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 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
- NCT07824869
- Sponsor's protocol ID
- HLX22-BC202
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC
- ClinicalTrials.gov ID
- NCT07824869
- Acronym / sponsor ID
- HLX22-BC202
- Conditions
- HER2 + Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 4 Dec 2029 (estimated)
- First posted
- 17 Sep 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 phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).
Detailed description
Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: HLX22, Drug: Trastuzumab, Drug: Capecitabine, Drug: Paclitaxel, Drug: Docetaxel, Drug: Eribulin, Drug: VinorelbineHLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine) |
| Control group | Placebo comparator | Drug: Trastuzumab, Drug: Capecitabine, Drug: Paclitaxel, Drug: Docetaxel, Drug: Eribulin, Drug: Vinorelbineplacebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
- Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
- HER2 positive confirmed by central laboratory.
- Hormone receptor (HR) status confirmed by local laboratory.
Key exclusion criteria (12 listed)
- History of any other malignancy within 2 years prior to signing the ICF.
- Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m2.
- Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
- Uncontrolled or severe cardiovascular disease.
- History of cerebrovascular accident within 6 months prior to randomization.
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 |
|---|---|---|
| HLX2215 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W | Drug | Experimental group |
| TrastuzumabLoading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1. | Drug | Control group, Experimental group |
| Capecitabine1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W | Drug | Control group, Experimental group |
| Paclitaxel175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV | Drug | Control group, Experimental group |
| Docetaxel75-100 mg/m2, D1, Q3W, IV | Drug | Control group, Experimental group |
| Eribulin1.4 mg/m2, D1 and D8, Q3W, IV | Drug | Control group, Experimental group |
| Vinorelbine25-30 mg/m2, D1 and D8, Q3W, IV | Drug | Control group, Experimental group |
Primary outcome
Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2 years
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1
6 secondary outcomes
Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1
Time frame: up to 5 years
ORR assessed by the investigator as per RECIST 1.1
Time frame: up to 2 years
PFS assessed by the investigator as per RECIST 1.1
Time frame: up to 5 years
Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 5 years
Adverse Events (AEs)
Time frame: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years
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 17 Sep 2026.
Related trials for HER2 + Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX22, Trastuzumab and Capecitabine 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 12 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 17 Sep 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mingxia Xu (+86 18905266695, Mingxia_Xu@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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: Up to 2 years). 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 17 Sep 2026.