Advanced Breast CancerPhase 3NCT07684456
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
A Phase 3 study testing Utidelone Capsule, Utidelone Injection and Capecitabine in people with Advanced Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Utidelone Capsule, Utidelone Injection and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Mar 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
- Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form.
- Subjects aged ≥18 and ≤75.
- Male or female subjects with ECOG performance status scored 0-1.
- Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology.
- Patients with locally advanced,recurrent,or metastatic breast cancer.
- Patients who had received chemotherapy regimens, including at least one taxanes or anthracyclines.
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- Patients with hormone receptor positive should have disease progression after endocrine therapy.
- At least one measurable lesion present according to RECIST 1.1 criteria.
- Expected survival time ≥ 12 weeks
- Baseline routine blood tests is normal.
- Liver and kidney function test results are normal.
- Fertile males and females of childbearing potential must agree to use effective contraception (so do their partners, using hormonal or barrier contraception, or abstinence) during the study and within at least 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing potential prior to enrollment must be negative.
Who cannot join
- Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration.
- Patients who have used Capecitabine or Utidelone within 6 months prior to randomization.
- Patients with breast cancer with CNS metastases leptomeningeal metastases.
- Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions.
- Patients with uncontrollable pleural effusion,pericardial effusion or ascites requiring repeated drainage(once a month or more)
- Patients with serious cardiovascular disease.
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- Patients with mental illnesses which are hard to control, patients who lack legal capacity or have limited legal capacity.
- Patients with gastrointestinal disorders affecting oral administration.
- Patients with active infections and need systemic therapy currently.
- Patients with peripheral neuropathy grade≥2 during randomization.
- Patients with toxicity grade ≥2 which caused by prior anti-tumor therapy.(NCI-CTCAE 5.0,except for what is considered no safety risk such as alopecia by investigator.）
- Patients who have received any major surgery(except for diagnostic procedures such as biopsy）,or have sustained major trauma within 4 weeks to randomization;or is expected to undergo major surgery during the treatment.
- Patients who have received radiotherapy within 2 weeks to randomization.
- Patients who have received interventional therapy in another clinical trail or have received other investigational treatments.
- Patients with other malignant tumor within 5 years to randomization excluding curatively treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma, and papillary thyroid carcinoma.
- Patients with allergy of caster oil:patients with previous fluorouracil medication history with severe allergy or known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Pregnant or lactating patients.
- Patients who, in the opinion of the investigator, are not suitable to participate in this study.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Binghe Xu
About this study
Official title: A Randomized,Controlled Phase III Study on Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- Utidelone Capsule, Utidelone Injection, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone CapsuleDrug
Utidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.
Utidelone InjectionDrug
Utidelone Injection：30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.
CapecitabineDrug
Capecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Utidelone Capsule combined with Capecitabine | Experimental | Not described Receives: Drug: Utidelone Capsule; Drug: Capecitabine |
| Utidelone Injection combined with Capecitabine | Active comparator | Not described Receives: Drug: Utidelone Injection; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
To evaluate the Progression-Free Survival (PFS) of Utidelone capsules combined with Capecitabine compared with Utidelone Injection combined with Capecitabine
Measured: 6 weeks
Secondary outcomes (6)
Objective Response Rate
The percentage of patients who have a partial response or complete response to the treatment.
Measured: 6 weeks
Disease Control Rate
The proportion of patients who achieve a complete response , partial response , or stable disease as their best overall response.
Measured: 6 weeks
Duration of Response
The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Measured: 6 weeks
Time to Treatment Failure
The time from randomization to discontinuation of treatment due to any cause
Measured: 3 weeks
Median treatment cycle
Median number of actual treatment cycles completed by patients
Measured: 12 months
Treatment-related Adverse Event-TRAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684456
- Sponsor's protocol ID
- BG02-2601
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Controlled Phase III Study on Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07684456
- Acronym / sponsor ID
- BG02-2601
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 6 Jul 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 study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Utidelone Capsule combined with Capecitabine | Experimental | Drug: Utidelone Capsule, Drug: Capecitabine |
| Utidelone Injection combined with Capecitabine | Active comparator | Drug: Utidelone Injection, Drug: Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form.
- Subjects aged ≥18 and ≤75.
- Male or female subjects with ECOG performance status scored 0-1.
- Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology.
- Patients with locally advanced,recurrent,or metastatic breast cancer.
Key exclusion criteria (18 listed)
- Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration.
- Patients who have used Capecitabine or Utidelone within 6 months prior to randomization.
- Patients with breast cancer with CNS metastases leptomeningeal metastases.
- Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions.
- Patients with uncontrollable pleural effusion,pericardial effusion or ascites requiring repeated drainage(once a month or more)
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 |
|---|---|---|
| Utidelone CapsuleUtidelone Capsule: 60 mg/m2/d, administered once a day orally continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. | Drug | Utidelone Capsule combined with Capecitabine |
| Utidelone InjectionUtidelone Injection：30 mg/m2/d, administered once a day intravenously, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. | Drug | Utidelone Injection combined with Capecitabine |
| CapecitabineCapecitabine: 1000mg/m2, twice a day continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle. | Drug | Utidelone Capsule combined with Capecitabine, Utidelone Injection combined with Capecitabine |
Primary outcome
Progression-Free Survival
Time frame: 6 weeks
To evaluate the Progression-Free Survival (PFS) of Utidelone capsules combined with Capecitabine compared with Utidelone Injection combined with Capecitabine
6 secondary outcomes
Objective Response Rate
Time frame: 6 weeks
Disease Control Rate
Time frame: 6 weeks
Duration of Response
Time frame: 6 weeks
Time to Treatment Failure
Time frame: 3 weeks
Median treatment cycle
Time frame: 12 months
Treatment-related Adverse Event-TRAE
Time frame: 12 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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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?
A Phase 3 study testing Utidelone Capsule, Utidelone Injection and Capecitabine in people with Advanced Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. 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 12 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 6 Jul 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.
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 Rongguo Qiu (010-56315388, Rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 6 weeks). 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 6 Jul 2026.