Recruiting soon

HB1801 Versus Taxotere® for Advanced Breast Cancer

What is being tested

HB1801

+ Taxotere®

Drug

Who is being recruted

Over 18 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: August 2025

See protocol details

Summary

Principal SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study ContactClinical Trials Information Group officer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to compare the effectiveness and safety of a new treatment, HB1801, against an existing medication, Taxotere®, for individuals with advanced breast cancer. The study is important as it seeks to find more effective treatment options for those who have progressed to an advanced stage of this disease. Enrolling 60 participants, the trial hopes to improve outcomes by potentially offering a better alternative treatment that could help manage symptoms and slow disease progression. Participants will first go through a screening to ensure they meet the study criteria. Those selected will then enter a treatment period where they receive either HB1801 or Taxotere®. HB1801 is a form of Docetaxel administered as an injection combined with albumin to enhance delivery. The trial is open-label, meaning both researchers and participants know which treatment is being administered. Throughout the study, researchers will monitor health and treatment effects to assess safety and efficacy. After the treatment phase, there will be a follow-up period to continue observing the participants' health and gather long-term data on the treatment's effects.

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

NCT07083505

Principal SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study ContactClinical Trials Information Group officer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

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.

Show More Criteria

18 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

HB1801 \[administered according to the clinical trial protocol\]

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers