HER2-Negative Advanced Breast CancerPhase 3NCT07805135
A Study of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer
A Phase 3 study testing HB1801 and Docetaxel (Taxotere®) in people with HER2-Negative Advanced Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a randomized, open-label, multicenter Phase Ⅲ clinical trial designed to evaluate the efficacy and safety of HB1801 versus Taxotere® in patients with HER2-negative advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-Negative Advanced Breast Cancer
- What is being tested?
- HB1801 and Docetaxel (Taxotere®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 1 Jun 2029
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18-75 years (Whichever is on the day of signing the informed consent form).
- 2. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent/metastatic stage, with the requirements below based on the most recent pathological report:
- HER2-negative confirmed by histological or cytological testing;
- Pathological report is available to confirm HR status.
- 3. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
- 4. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
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- 5. Has adequate organ and system functions within 7 days prior to the first dose.
- 6. Eastern Cooperative Oncology Group performance status of 0 or 1.
- 7. Expected survival ≥ 3 months.
Who cannot join
- 1. Has received prior taxane-containing single-agent or combination regimens, and have disease progression during salvage therapy for unresectable locally advanced or metastatic breast cancer (has received at least 2 cycles), or developed recurrent-metastatic disease within 12 months following adjuvant therapy.
- 2. History of severe allergy or hypersensitivity reactions (Grade ≥3 per NCI-CTCAE Version 6.0) to human serum albumin or docetaxel and/or contraindications thereto, or history of severe allergy and/or contraindications to glucocorticoids.
- 3. Untreated active brain metastases (including brain or leptomeningeal metastases). Subjects with treated brain metastases may be enrolled if lesions are stable without evidence of new or enlarging pre-existing brain metastases.
- 4. With a history of other primary malignant tumors within 5 years before administration.
- 5. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.
- 6. Severe neurological diseases (e.g., epilepsy, dementia, etc.) and Grade ≥2 peripheral neuropathy.
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- 7. Receipt of systemic glucocorticoid therapy within 14 days prior to the first dose.
- 8. Current clinically significant abnormal interstitial lung disease.
- 9. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose.
- 10. Has arterial or venous thromboembolism (e.g., lower-extremity deep vein thrombosis, lower-extremity arterial embolism, pulmonary embolism, etc.) within 6 months prior to the first dose. Stable thrombus is permitted for enrollment if the Investigator assesses no associated cardiovascular risk.
- 11. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks prior to the first dose.
- 12. Has undergone major visceral organ surgery (excluding puncture biopsy or infusion device implantation) within 4 weeks prior to the first dose, or who require major visceral organ surgery during the study period.
- 13. Receipt of chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or other investigational study drug within 4 weeks or 5 half-lives prior to the first dose (whichever is shorter, with a minimum of 2 weeks); receipt of radiotherapy within 2 weeks prior to the first dose; receipt of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose.
- 14. Toxicities from all prior anti-tumor therapies have not recovered to Grade 1 or less prior to the first dose.
- 15. Has received powerful CYP3A4 inhibitor or inducer within 2 weeks before the first dose.
- 16. Has active hepatitis B infection, hepatitis C infection, positive HIV antibody, or active syphilis.
- 17. Concurrent participation in another interventional clinical study.
- 18. Any other conditions that, in the Investigator's opinion, render the participant unsuitable for participation in this clinical trial.
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 Randomized, Open-Label, Multicenter Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer
This is a randomized, open-label, multicenter Phase Ⅲ clinical trial designed to evaluate the efficacy and safety of HB1801 versus Taxotere® in patients with HER2-negative advanced breast cancer.
- Conditions
- HER2-Negative Advanced Breast Cancer
- Being tested
- HB1801, Docetaxel (Taxotere®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB1801Drug
HB1801, 100 mg/m² in Cycle 1, 75 mg/m² starting from Cycle 2, once every 3 weeks (Q3W), intravenous infusion over 60 minutes.
Docetaxel (Taxotere®)Drug
Docetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HB1801 | Experimental | Not described Receives: Drug: HB1801 |
| Docetaxel (Taxotere®) | Experimental | Not described Receives: Drug: Docetaxel (Taxotere®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of progressive disease (as per RECIST v1.1) or death due to any cause.
Measured: up to approximately 2 years after the first enrollment
Secondary outcomes (6)
Objective Response Rate (ORR) assessed per RECIST v1.1
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with complete response (CR) or partial response (PR).
Measured: up to approximately 2 years after the first enrollment
Duration of Response (DOR)
DOR by investigator assessment according to RECIST 1.1 in participants with CR or PR, defined as the time from the first documented CR/PR to PD or death.
Measured: up to approximately 2 years after the first enrollment
Disease Control Rate (DCR)
DCR by investigator assessment according to RECIST 1.1, defined as the percentage of participants with CR, PR, or stable disease (SD) lasting at least 6 weeks.
Measured: up to approximately 2 years after the first enrollment
Overall Survival (OS)
OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from study therapy or received another subsequent anticancer therapy.
Measured: up to approximately 2 years after the first enrollment
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Measured: up to approximately 2 years after the first enrollment
Plasma concentration of docetaxel (free and total)
Measured: After completion of infusion administration on Day 1 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Negative Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 1:1 ratio to receive treatment in either the experimental group (HB1801) or the control group (Taxotere®).
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805135
- Sponsor's protocol ID
- HB1801-017
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07805135
- Acronym / sponsor ID
- HB1801-017
- Conditions
- HER2-Negative Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 4 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 randomized, open-label, multicenter Phase Ⅲ clinical trial designed to evaluate the efficacy and safety of HB1801 versus Taxotere® in patients with HER2-negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 1:1 ratio to receive treatment in either the experimental group (HB1801) or the control group (Taxotere®).
| Arm | Type | Receives |
|---|---|---|
| HB1801 | Experimental | Drug: HB1801 |
| Docetaxel (Taxotere®) | Experimental | Drug: Docetaxel (Taxotere®) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age: 18-75 years (Whichever is on the day of signing the informed consent form).
- 2. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent/metastatic stage, with the requirements below based on the most recent pathological report:
- 3. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
- 4. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
- 5. Has adequate organ and system functions within 7 days prior to the first dose.
Key exclusion criteria (18 listed)
- 1. Has received prior taxane-containing single-agent or combination regimens, and have disease progression during salvage therapy for unresectable locally advanced or metastatic breast cancer (has received at least 2 cycles), or developed recurrent-metastatic disease within 12 months following adjuvant therapy.
- 2. History of severe allergy or hypersensitivity reactions (Grade ≥3 per NCI-CTCAE Version 6.0) to human serum albumin or docetaxel and/or contraindications thereto, or history of severe allergy and/or contraindications to glucocorticoids.
- 3. Untreated active brain metastases (including brain or leptomeningeal metastases). Subjects with treated brain metastases may be enrolled if lesions are stable without evidence of new or enlarging pre-existing brain metastases.
- 4. With a history of other primary malignant tumors within 5 years before administration.
- 5. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.
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 |
|---|---|---|
| HB1801HB1801, 100 mg/m² in Cycle 1, 75 mg/m² starting from Cycle 2, once every 3 weeks (Q3W), intravenous infusion over 60 minutes. | Drug | HB1801 |
| Docetaxel (Taxotere®)Docetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes. | Drug | Docetaxel (Taxotere®) |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to approximately 2 years after the first enrollment
PFS was defined as the time from the date of randomization to the date of progressive disease (as per RECIST v1.1) or death due to any cause.
6 secondary outcomes
Objective Response Rate (ORR) assessed per RECIST v1.1
Time frame: up to approximately 2 years after the first enrollment
Duration of Response (DOR)
Time frame: up to approximately 2 years after the first enrollment
Disease Control Rate (DCR)
Time frame: up to approximately 2 years after the first enrollment
Overall Survival (OS)
Time frame: up to approximately 2 years after the first enrollment
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time frame: up to approximately 2 years after the first enrollment
Plasma concentration of docetaxel (free and total)
Time frame: After completion of infusion administration on Day 1 of Cycle 1
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 4 Sep 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 3 study testing HB1801 and Docetaxel (Taxotere®) in people with HER2-Negative Advanced 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 9 inclusion and 18 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 4 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. 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 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 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?
Progression-free Survival (PFS) (time frame: up to approximately 2 years after the first enrollment). 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 4 Sep 2026.