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HER2-positive Breast CancerPhase 2NCT07116824

HB1801 Combined Treatment of HER2-positive Breast Cancer

A Phase 2 study testing HB1801, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
HB1801, Trastuzumab and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
15 Sep 2025to 7 Nov 2027
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

  • Voluntarily participate in this study and sign the Informed Consent Form (ICF);
  • Age ≥ 18 years;
  • Histologically and/or cytologically confirmed unresectable locally recurrent or metastatic breast cancer;
  • HER2-positive (IHC 3+, or IHC 2+ with ISH-positive);
  • No prior systemic chemotherapy and/or HER2-targeted therapy for unresectable locally recurrent or metastatic breast cancer (participants who have received ≤1 line of endocrine therapy are eligible); Participants who relapsed >12 months after completing (neo)adjuvant chemotherapy or HER2-targeted therapy may be considered for enrollment;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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  • At least one measurable lesion per RECIST 1.1. The measurable lesion should not have received local treatment such as radiotherapy (lesions in previously irradiated areas may be selected as target lesions if progression is confirmed). Target lesions cannot be bone-only metastases;
  • Adequate organ and bone marrow function (without transfusion or hematopoietic growth factor support within 14 days prior to testing):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
  • Platelet count ≥ 100 × 10^9/L;
  • Hemoglobin ≥ 90 g/L;
  • Liver function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT/AST≤ 5 × ULN for participants with liver metastases; AST/ALT ≤ 1.5 × ULN for participants with alkaline phosphatase (ALP) > 2.5 × ULN);
  • Renal function: Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula);
  • Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for participants receiving anticoagulation therapy, the investigator should confirm that INR and APTT are within safe and effective therapeutic ranges);
  • Left ventricular ejection fraction (LVEF) > 50%;
  • Expected survival ≥ 3 months;
  • For women of childbearing potential: Negative serum pregnancy test within 7 days before randomization and agreement to use reliable contraception during the study and for 3 months after last dose of docetaxel/HB1801 or 7 months after last dose of trastuzumab/pertuzumab (whichever is longer). For male participants with partners of childbearing potential: Agreement to use reliable contraception during the study and for 3 months after last dose of docetaxel/HB1801 or 7 months after last dose of trastuzumab/pertuzumab (whichever is longer).

Who cannot join

  • Contraindications to trastuzumab, pertuzumab, or docetaxel, or deemed by the investigator as unsuitable for treatment with HB1801, docetaxel, pertuzumab, or trastuzumab;
  • Participants with ≥ Grade 3 peripheral neuropathy at randomization;
  • Toxicities from prior anticancer therapy have not resolved to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, peripheral neuropathy, or laboratory abnormalities deemed non-risky by the investigator, which must be ≤ Grade 2);
  • History of LVEF decline to < 50%, symptomatic congestive heart failure (CHF), or toxicity leading to permanent discontinuation during prior HER2-targeted therapy;
  • Known hypersensitivity or contraindications to corticosteroids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.);
  • Prior anthracycline therapy exceeding cumulative doses of: Doxorubicin or liposomal doxorubicin > 360 mg/m², Epirubicin > 720 mg/m², Mitoxantrone > 120 mg/m², Other anthracyclines > doxorubicin-equivalent 360 mg/m²(If multiple anthracyclines were used, the total dose must not exceed 360 mg/m² doxorubicin-equivalent);
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  • Use of strong CYP3A4 inhibitors within 14 days before randomization;
  • History of hypersensitivity to any study drug component or excipients;
  • Untreated or unstable brain/spinal metastases, leptomeningeal disease, or cord compression (participants with treated, asymptomatic CNS lesions stable for ≥4 weeks on imaging, without edema, and off corticosteroids may be eligible);
  • Active malignancies within 3 years prior to randomization, except: studied breast cancer, locally cured tumors (e.g., resected basal/squamous skin cancer, superficial bladder cancer, cervical/breast carcinoma in situ, early-stage thyroid cancer);
  • Uncontrolled or significant cardiovascular disease, including:
  • NYHA Class II+ CHF, unstable angina, myocardial infarction, or hemodynamically unstable arrhythmia within 6 months;
  • Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive);
  • Clinically significant QTc prolongation (Fridericia-corrected QTcF > 450 ms at screening);
  • Arterial/venous thromboembolism within 6 months (e.g., stroke, TIA, DVT, PE);
  • Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg);
  • Active/chronic infection requiring systemic antimicrobial/antiviral therapy within 14 days (including tuberculosis);
  • Active hepatitis: HBV (HBsAg+ with HBV-DNA ≥ 2×10³ IU/mL), HCV (anti-HCV+ with detectable HCV-RNA) *Note: HBsAg+ carriers with HBV-DNA < 2×10³ IU/mL may enroll if willing to receive entecavir/antiviral therapy;*
  • Known HIV infection;
  • Concurrent participation in other interventional clinical trials (except observational studies or follow-up phases) or <4 weeks since last dose in prior interventional trials;
  • Anticancer therapy within 28 days (radiotherapy, targeted/immunotherapy, investigational drugs) or 14 days (traditional Chinese medicine with antitumor indications);
  • Uncontrolled effusions requiring frequent drainage/medical intervention within 7 days (e.g., pleural, ascites, pericardial) or needing re-intervention within 2 weeks (excluding cytology);
  • Major surgery within 28 days (excluding biopsies);
  • Pregnant or lactating women;
  • Other conditions compromising study participation/benefit (e.g., psychiatric disorders, substance abuse, or clinically significant comorbidities).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Phase II Trial to Evaluate the Safety and Efficacy of HB1801 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.

Being tested
HB1801, Trastuzumab, Pertuzumab, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB1801Drug

    HB1801 is administered by intravenous infusion.

  • TrastuzumabDrug

    Trastuzumab is administered by intravenous infusion, 8mg/kg loading dose and then 6mg/kg per cycle, Q3W.

  • PertuzumabDrug

    Pertuzumab is administered by intravenous infusion, 840mg loading dose and then 420mg per cycle, Q3W.

  • DocetaxelDrug

    Docetaxel is administered by intravenous infusion, 75mg/m^2, Q3W.

Study groups in NCT07116824
Study groupRoleWhat they receive
Cohort 1：Combination of HB1801, Trastuzumab and PertuzumabExperimentalHB1801: per protocol; Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W
Receives: Drug: HB1801; Drug: Trastuzumab; Drug: Pertuzumab
Cohort 2：Combination of Docetaxel, Trastuzumab and PertuzumabActive comparatorDocetaxel：75mg/m^2 ，Q3W Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as assessed by RECIST 1.1

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Disease Control Rate (DCR) as assessed by RECIST 1.1

    Measured: Up to approximately 2 years

  2. Duration of Response (DoR) as assessed by RECIST 1.1

    Measured: Up to approximately 2 years

  3. Progression-free survival (PFS) as assessed by RECIST 1.1

    Measured: Up to approximately 2 years

  4. Overall Survival (OS)

    Measured: Up to approximately 2 years

  5. Incidence and severity of treatment-emergent adverse events (TEAE)

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion7 Nov 2027 (estimated)

Resources

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
Model description
This is an open-label, multi-center, randomized, Phase II clinical study.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07116824
Sponsor's protocol ID
HB1801-014
Status last verified
Aug 2025
First submitted
7 Aug 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HB1801, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 17 inclusion and 25 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 12 Aug 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 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as assessed by RECIST 1.1 (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07116824.

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 12 Aug 2025.

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