HER2-negative Breast Cancer Patients With Brain MetastasesPhase 2NCT06764940
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
A Phase 2 study testing Utidelone and Utidelone in combination with capecitabine in people with HER2-negative Breast Cancer Patients With Brain Metastases, run by Biostar Pharma, Inc. at 12 sites in United States.
Trial summary
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-negative Breast Cancer Patients With Brain Metastases
- What is being tested?
- Utidelone and Utidelone in combination with 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
- 120 participants
- Where
- 12 sitesUnited States
- Study dates
- 14 Jul 2025to 15 Jul 2027
- 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
- Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH).
- Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) .
- Male or female aged ≥18 years.
- ECOG PS 0 or 1.
- Have a life expectancy of at least 3 months.
- Have adequate baseline hematologic parameters.
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- Have adequate hepatic and renal function.
- ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
- Women of childbearing potential, unless hysterectomy or oophorectomy or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Investigator will discuss with patient on the above points and the patient agreement will be documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose.
- Patients must be able to follow the study visit schedule, and must be able of sign and give informed consent in accordance with institutional review board.
Who cannot join
- Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology.
- Any intracranial lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
- Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
- Had evidence of intracranial hemorrhage within 3 months before study treatment.
- Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
- Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment.
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- Patients who have received anti-tumor therapies less than 2 weeks before the first dose of investigational product, including endocrine therapy, chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy or antibody-drug conjugate therapy.
- Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline.
- Patients with neuropathy> grade 1.
- Known hypersensitivity to any components of the investigational product.
- Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- This applies only to the combination cohort and does not apply to the monotherapy cohort. For patients with previous capecitabine treatment, the prior use of capecitabine meets any of the following criteria: A) The best response during prior capecitabine combination therapy or monotherapy is Progressive Disease (PD); B) Have received capecitabine treatment within 6 months prior to the first study treatment.
- Patients who are pregnant (positive pregnancy test) or lactating.
- Patients with other malignancies over the past 5 years, except for inactive tumors with good prognosis, including resected basal cell and squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, or papillary thyroid cancer.
- Patients who are particpating in other interventional studies or who are receiving other study treatments (patients who have discontinued other investigational treatments and are in follow-up are eligible for enrollement in this study).
- Known active or uncontrolled hepatitis B infection, active syphilis, or HIV infection that is not well controlled; or positive for hepatitis B virus based on the evaluation of results of tests for hepatitis B (HBsAg, anti-HBs, anti-HBc, or HBV DNA) infection at screening.
- With a history of severe or uncontrolled diseases.
- Autoimmune diseases requiring treatment with systemic glucocorticoids.
- Not able to perform contrast-enhanced brain MRI or known contraindications to MRI gadolinium contrast, such as cardiac pacemaker, shrapnel, or eye foreign body.
- Patients with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Dr. Priyanka Raval, praval@augusta.edu
Dr. Priyanka Raval
- Recruiting
University Of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Dr. Elena Shagisultanova, elena.shagisultanova@cuanschutz.edu
Dr. Elena Shagisultanova
- Recruiting
The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Solmaz Sahebjam, ssahebj1@jh.edu
Solmaz Sahebjam
- Recruiting
Robert H. Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, 60611
Dr. Regina Stein, rstein@nm.org
Dr. Regina Stein
- Recruiting
City of Hope--Duarte
Duarte, California, 91010
Dr. Hope S. Rugo, hrugo@coh.org
Dr. Hannah Chang, hanchang@coh.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Dr. Nuhad Ibrahim, nibrahim@mdanderson.org
Dr. Nuhad Ibrahim
- Recruiting
Community Clinical Trials
Kingwood, Texas, 22751
Dr. Saleha Sajid, sajidmd@communityclinicaltrials.com
Dr. Saleha Sajid
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Dr. Liawaty Ho, Liawaty.Ho@usoncology.com
Dr. Liawaty Ho
- Recruiting
Univ. of California Los Angeles
Los Angeles, California, 90095
Rena Callahan, rcallahan@mednet.ucla.edu
Rena Callahan
- Recruiting
Scripps Health
San Diego, California, 92121
Dr. Tresa McGranahan, mcgranahan.tresa@scrippshealth.org
Dr. Tresa McGranahan
- Recruiting
Stony Brook Cancer Center
Stony Brook, New York, 11794-7263
Dr. Lea Baer, Lea.Baer@stonybrookmedicine.edu
Dr. Lea Baer
- Recruiting
Tranquil Clinical Research
Webster, Texas, 77598
Dr. John G. Knecht III, joknecht29@gmail.com
Dr. John G. Knecht III
About this study
Official title: A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.
The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.
- Being tested
- Utidelone, Utidelone in combination with capecitabine
- Keywords
- breast cancer, brain metastases
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtideloneDrug
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
Utidelone in combination with capecitabineDrug
UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Utidelone in combination with capecitabineDrug
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
Utidelone in combination with capecitabineDrug
Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| (stage 1) monotherapy group | Experimental | Not described Receives: Drug: Utidelone |
| (stage 1) combination group A | Experimental | Not described Receives: Drug: Utidelone in combination with capecitabine |
| (stage 1) combination group B | Experimental | Not described Receives: Drug: Utidelone in combination with capecitabine |
| (stage 2) combination group | Experimental | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Measured: 12 months
Secondary outcomes (10)
IC-ORR evaluated by investigator according to Neuro-Oncology Brain Metastases criteria (RANO-BM).
Measured: 12 months
ORR according to RECIST 1.1 criteria.
Measured: 12 months
Progression Free Survival (PFS) according to RECIST 1.1 criteria.
Measured: 12 months
Disease Control Rate (DCR) according to RECIST 1.1 criteria.
Measured: 12 months
Duration of Response (DOR) according to RECIST 1.1 criteria.
Measured: 12 months
Intracranial Progression Free Survival (IC-PFS) according to RECIST 1.1 criteria and RANO-BM.
Measured: 12 months
Intracranial Disease Control Rate (IC-DCR) according to RECIST 1.1 criteria and RANO-BM.
Measured: 12 months
Intracranial Duration of Response (IC-DOR) according to RECIST 1.1 criteria and RANO-BM.
Measured: 12 months
Overall Survival (OS)
Measured: up tp 24 months
Treatment-emergent Adverse Event-TEAE
Measured: Until 28 days after the last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start14 Jul 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast Cancer Patients With Brain MetastasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biostar Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764940
- Sponsor's protocol ID
- BG01-2402
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT06764940
- Acronym / sponsor ID
- BG01-2402
- Keywords
- breast cancer, brain metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Biostar Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 9 Jan 2025 (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 multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine.
The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (stage 1) monotherapy group | Experimental | Drug: Utidelone |
| (stage 1) combination group A | Experimental | Drug: Utidelone in combination with capecitabine |
| (stage 1) combination group B | Experimental | Drug: Utidelone in combination with capecitabine |
| (stage 2) combination group | Experimental | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH).
- Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) .
- Male or female aged ≥18 years.
- ECOG PS 0 or 1.
- Have a life expectancy of at least 3 months.
Key exclusion criteria (20 listed)
- Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology.
- Any intracranial lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
- Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
- Had evidence of intracranial hemorrhage within 3 months before study treatment.
- Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
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 |
|---|---|---|
| UtideloneUtidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle. | Drug | (stage 1) monotherapy group |
| Utidelone in combination with capecitabineUTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle. | Drug | (stage 1) combination group B |
| Utidelone in combination with capecitabineUtidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle. | Drug | (stage 1) combination group A |
| Utidelone in combination with capecitabineUtidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle. | Drug | – |
Primary outcome
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Time frame: 12 months
10 secondary outcomes
IC-ORR evaluated by investigator according to Neuro-Oncology Brain Metastases criteria (RANO-BM).
Time frame: 12 months
ORR according to RECIST 1.1 criteria.
Time frame: 12 months
Progression Free Survival (PFS) according to RECIST 1.1 criteria.
Time frame: 12 months
Disease Control Rate (DCR) according to RECIST 1.1 criteria.
Time frame: 12 months
Duration of Response (DOR) according to RECIST 1.1 criteria.
Time frame: 12 months
Intracranial Progression Free Survival (IC-PFS) according to RECIST 1.1 criteria and RANO-BM.
Time frame: 12 months
Intracranial Disease Control Rate (IC-DCR) according to RECIST 1.1 criteria and RANO-BM.
Time frame: 12 months
Intracranial Duration of Response (IC-DOR) according to RECIST 1.1 criteria and RANO-BM.
Time frame: 12 months
Overall Survival (OS)
Time frame: up tp 24 months
Treatment-emergent Adverse Event-TEAE
Time frame: Until 28 days after the last dose of treatment
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 21 Aug 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Utidelone and Utidelone in combination with capecitabine in people with HER2-negative Breast Cancer Patients With Brain Metastases, run by Biostar Pharma, Inc. at 12 sites in United States.
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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 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 Simon Guan (+86 10 67864938, simon.guan@biostar-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria. (time frame: 12 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 21 Aug 2026.