Breast CancerNCT07899047
Albumin-Bound Paclitaxel (Ⅱ) in Patients With Advanced Breast Cancer
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Experimental Group
- Type of treatment
- Injection or infusion
- How many people
- 1,372 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to May 2030
- Phase
- Observational
- 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
Study population: HER2-negative recurrent or metastatic breast cancer
Who may be able to join
- Aged ≥ 18 years;
- Histologically and/or cytologically confirmed HER2-negative recurrent or metastatic breast cancer (HER2-negative subtype includes HR-positive HER2-negative and triple-negative breast cancer);
- No restrictions on prior lines or regimens for recurrent/metastatic disease (e.g., endocrine therapy, CDK4/6 inhibitors, ADC agents, chemotherapy, immunotherapy, etc.). For patients previously exposed to taxane-based therapy in the neoadjuvant, adjuvant, or metastatic-disease setting, recurrence or disease progression must have occurred > 12 months after the last taxane administration;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion per RECIST version 1.1. Patients with bone-only metastases without measurable lesions are eligible;
- Planned to receive monotherapy or combination regimens containing either Paclitaxel for Injection (Albumin Bound) (Ⅱ) or paclitaxel for injection (albumin-bound). Combination partners include, but are not limited to, PD-1 inhibitors, capecitabine, gemcitabine, cisplatin, and carboplatin;
- Fully informed and voluntarily provides written informed consent for study participation.
Who cannot join
- Known hypersensitivity or intolerance to study drugs or their excipients;
- Concurrent participation in other interventional clinical studies;
- Uncontrolled third-space effusions (e.g., massive pleural, peritoneal, pericardial effusion) that cannot be stabilized (i.e., no further intervention required after drainage). Patients with small, asymptomatic pleural or peritoneal effusions identified by imaging are permitted;
- History of malignancies other than breast cancer within 5 years prior to the first study drug dose, except for cured malignancies such as in-situ carcinoma and basal-cell carcinoma;
- Active brain metastases (including symptomatic brain metastases or leptomeningeal metastases).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jing Yao, 027-85726375, jeaneyph@126.com
About this study
Official title: Efficacy, Safety, and Cost-Effectiveness of Albumin-Bound Paclitaxel (Ⅱ) in Chinese Patients With Advanced Breast Cancer: A Multicenter, Observational, Real-World Study
This is a multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer.
- Being tested
- Experimental Group, control group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regimens containing paclitaxel for injection (albumin bound) (Ⅱ)
control groupDrug
Regimens containing paclitaxel for injection (albumin bound)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described Receives: Drug: Experimental Group | |
| Control group | Not described Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from the participant's first study-drug administration to death from any cause.
Measured: 42 months
Secondary outcomes (8)
Objective Response Rate (ORR)
Proportion of participants achieving best overall tumour response of complete response (CR) or partial response (PR), assessed per RECIST version 1.1.
Measured: 42 months
Disease Control Rate (DCR)
Proportion of participants achieving best overall tumour response of CR, PR, or stable disease (SD), assessed per RECIST version 1.1.
Measured: 42 months
Progression-Free Survival (PFS)
Time from the participant's first study-drug administration to tumour progression or death from any cause, whichever occurs first.
Measured: 42 months
Safety
Incidence and severity of adverse events occurring throughout the study period.
Measured: 42 months
Incidence of rash within the first two cycles and over all treatment cycles
Incidence and severity of rash events occurring within the specified treatment periods.
Measured: 42 months
Health-related quality of life
EQ-5D-5L questionnaire scores collected at each study visit, which will be converted into health utility values for the Chinese general population.
Measured: 42 months
Time from preparation start to complete dispersion
At Cycle 1, when preparing the first vial of study drug.
Measured: 42 months
Health-economic outcomes
Health-economic outcomes include real-world direct medical costs and QALYs derived from EQ-5D-5L. Cost-effectiveness will be evaluated by calculating the ICER to compare the two albumin-bound paclitaxel regimens.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,372 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YaoJing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899047
- Sponsor's protocol ID
- CSPC-XBZ-BC-K01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Cost-Effectiveness of Albumin-Bound Paclitaxel (Ⅱ) in Chinese Patients With Advanced Breast Cancer: A Multicenter, Observational, Real-World Study
- ClinicalTrials.gov ID
- NCT07899047
- Acronym / sponsor ID
- CSPC-XBZ-BC-K01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,372 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 27 Oct 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 multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Drug: Experimental Group |
| Control group | – | Drug: control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2-negative recurrent or metastatic breast cancer
Key inclusion criteria (7 listed)
- Aged ≥ 18 years;
- Histologically and/or cytologically confirmed HER2-negative recurrent or metastatic breast cancer (HER2-negative subtype includes HR-positive HER2-negative and triple-negative breast cancer);
- No restrictions on prior lines or regimens for recurrent/metastatic disease (e.g., endocrine therapy, CDK4/6 inhibitors, ADC agents, chemotherapy, immunotherapy, etc.). For patients previously exposed to taxane-based therapy in the neoadjuvant, adjuvant, or metastatic-disease setting, recurrence or disease progression must have occurred > 12 months after the last taxane administration;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- At least one measurable lesion per RECIST version 1.1. Patients with bone-only metastases without measurable lesions are eligible;
Key exclusion criteria (5 listed)
- Known hypersensitivity or intolerance to study drugs or their excipients;
- Concurrent participation in other interventional clinical studies;
- Uncontrolled third-space effusions (e.g., massive pleural, peritoneal, pericardial effusion) that cannot be stabilized (i.e., no further intervention required after drainage). Patients with small, asymptomatic pleural or peritoneal effusions identified by imaging are permitted;
- History of malignancies other than breast cancer within 5 years prior to the first study drug dose, except for cured malignancies such as in-situ carcinoma and basal-cell carcinoma;
- Active brain metastases (including symptomatic brain metastases or leptomeningeal metastases).
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 |
|---|---|---|
| Experimental GroupRegimens containing paclitaxel for injection (albumin bound) (Ⅱ) | Drug | Experimental Group |
| control groupRegimens containing paclitaxel for injection (albumin bound) | Drug | Control group |
Primary outcome
Overall Survival (OS)
Time frame: 42 months
Time from the participant's first study-drug administration to death from any cause.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: 42 months
Disease Control Rate (DCR)
Time frame: 42 months
Progression-Free Survival (PFS)
Time frame: 42 months
Safety
Time frame: 42 months
Incidence of rash within the first two cycles and over all treatment cycles
Time frame: 42 months
Health-related quality of life
Time frame: 42 months
Time from preparation start to complete dispersion
Time frame: 42 months
Health-economic outcomes
Time frame: 42 months
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 27 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 5 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Jing Yao (027-85726375, jeaneyph@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 42 months). 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 27 Oct 2026.