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Advanced Breast CancerPhase 2NCT07083505

A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer

A Phase 2 study testing HB1801 and Taxotere® in people with Advanced 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
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Trial summary

This is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of HB1801 compared with Taxotere® in patients with advanced breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
HB1801 and Taxotere®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 31 Dec 2026
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

  • 1. Age ≥ 18 years old (based on the date of signing the informed consent form).
  • 2. Voluntarily participate in this clinical trial, sign the informed consent form, and be willing and able to adhere to the treatment, visits, and related procedures specified in the protocol.
  • 3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer, meeting the following criteria: a) The investigator determines that the patient is suitable for single-agent docetaxel treatment, in accordance with the 2025 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Treatment Guidelines. b) At least one measurable lesion according to RECIST 1.1 criteria. For lesions previously treated with radiotherapy, the lesion can only be included as a measurable lesion if clear disease progression occurs after radiotherapy.
  • 4. Within 7 days before randomization, major organ/system functions are basically normal, meeting the criteria as assessed by laboratory tests.
  • 5. ECOG performance status of 0-1 within 7 days before randomization.
  • 6. Expected survival time ≥ 3 months.
  • 7. For women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days before randomization. The subject and spouse must agree to use effective contraception from the date of signing the informed consent until 6 months after the last study drug administration. During this period: Female subjects must not be lactating; Male subjects must avoid sperm donation.

Who cannot join

  • 1. Prior treatment with docetaxel monotherapy or combination therapy for unresectable locally advanced or metastatic breast cancer.
  • 2. Subjects with partially or completely intestinal obstruction that cannot be relieved by active treatment; history of inflammatory bowel disease, chronic diarrhea, or gastrointestinal bleeding.
  • 3. Known severe allergic history or hypersensitivity (NCI-CTCAE v5.0, ≥ grade 3) to human albumin or docetaxel, and/or contraindications; known severe allergic history and/or contraindications to glucocorticoids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.).
  • 4. Untreated active brain metastases (including symptomatic brain metastases or leptomeningeal metastases); subjects with treated brain metastases are eligible if the metastatic lesions are stable (brain imaging demonstrates stability for at least 4 weeks before randomization, no new neurological symptoms or neurological symptoms have returned to baseline, and no hormonal therapy is required for at least 14 days before randomization for investigational treatment), and there is no evidence of new or enlarged pre-existing brain metastases.
  • 5. History of other malignant tumors within 5 years before randomization, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, or in-situ carcinoma (e.g., cervical in-situ carcinoma).
  • 6. Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring frequent drainage or medical intervention within 14 days before randomization, or requiring additional intervention within 2 weeks after intervention (excluding exfoliative cytology of exudates).
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  • 7. Severe neurological diseases (e.g., epilepsy, dementia) and ≥ grade 3 peripheral neuropathy.
  • 8. Severe respiratory diseases, such as asthma requiring glucocorticoid use, chronic obstructive pulmonary disease (acute exacerbation phase), etc.
  • 9. History of severe cardiovascular diseases within 6 months before randomization, including but not limited to: 1)Uncontrolled hypertension (defined as sustained systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication); 2)Severe arrhythmias and conduction abnormalities requiring anti-arrhythmic drugs other than β-blockers or digoxin (except atrial fibrillation and paroxysmal supraventricular tachycardia); 3)History of myocardial infarction, unstable angina, angioplasty, coronary artery bypass surgery; 4)New York Heart Association (NYHA) class II or higher heart failure; 5)QTcF > 480 ms [QTcF = QT/(RR 0.33), where RR is normalized heart rate (60/heart rate)], calculated by Fridericia formula (if abnormal, average three consecutive measurements taken 2 minutes apart); 6)Other clinically significant cardiac diseases as determined by the investigator.
  • 10. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks before randomization.
  • 11. Major organ surgery (except biopsy or infusion device implantation) within 4 weeks before randomization, or scheduled for major organ surgery during the trial.
  • 12. Chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter, but at least 2 weeks) before randomization; radiotherapy within 2 weeks before randomization; traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.
  • 13. Unresolved toxicities from prior anticancer therapy to grade 1 or lower (per CTCAE v5.0), except for grade 2 neuropathy, alopecia, hypothyroidism (with hormone replacement), and toxicities determined by the investigator to pose no safety risk.
  • 14. Use of strong CYP3A4 inhibitors or inducers within 2 weeks before randomization.
  • 15. Vaccination (including live and attenuated live vaccines) within 4 weeks before randomization or planned during the trial.
  • 16. Active hepatitis B infection (HBsAg-positive and HBV-DNA > ULN); hepatitis C infection (antibody-positive and HCV-RNA PCR-positive); human immunodeficiency virus (HIV) carrier; active tuberculosis or syphilis infection.
  • 17. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) study or follow-up of an interventional study.
  • 18. Other conditions deemed by the investigator as unsuitable for trial participation, including but not limited to severe or uncontrolled medical conditions interfering with trial result interpretation or trial compliance.

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 Multicenter, Randomized, Open-Label Phase II Clinical Trial Comparing Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer

This is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of HB1801 compared with Taxotere® in patients with advanced breast cancer. A total of 60 subjects with advanced breast cancer are planned to be enrolled.The trial consists of three phases: screening period, open-label treatment period, and follow-up period. HB1801 is Docetaxel for injection (Albumin-bound).

Being tested
HB1801, Taxotere®

What participants receive

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

  • HB1801Drug

    HB1801 [administered according to the clinical trial protocol]

  • Taxotere®Drug

    Taxotere® 75 mg/ m^2 [administered according to the clinical trial protocol]]

Study groups in NCT07083505
Study groupRoleWhat they receive
HB1801ExperimentalHB1801 [administered according to the clinical trial protocol]
Receives: Drug: HB1801
Taxotere®Active comparatorTaxotere® 75 mg/ m^2 [administered according to the clinical trial protocol]
Receives: Drug: Taxotere®

What is being measured

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

  1. Progressive-free Survival ( PFS)

    Measured: Up to 18months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Measured: Up to 18months

  2. Disease Control Rate (DCR)

    Measured: Up to 18months

  3. Duration of Response (DoR)

    Measured: Up to 18months

  4. Overall Survival (OS)

    Measured: Up to 18months

  5. Incidence and severity of Adverse Events (AEs)

    Measured: Up to 18months

Timeline

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

  1. First posted24 Jul 2025
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion11 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (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
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083505
Sponsor's protocol ID
HB1801-015
Status last verified
Jul 2025
First submitted
15 Jul 2025
Last updated
24 Jul 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 and Taxotere® in people with 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 7 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 24 Jul 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?

Progressive-free Survival ( PFS) (time frame: Up to 18months). 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 NCT07083505.

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 24 Jul 2025.

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