Metastatic Breast CancerPhase 2NCT06598046
A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined With Capecitabine in the Treatment of Active Brain Metastasis of TNBC
A Phase 2 study testing Utidelone and capecitabine in people with Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of the combination therapy of utidelone and capecitabine in the treatment of brain metastases from triple-negative advanced breast cancer, and to search for systemic treatment for brain metastases from triple-negative advanced breast cancer cases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Utidelone 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
- 48 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to 1 Aug 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Invasive breast cancer confirmed by histological or cytological examination, accompanied by metastatic disease; Patients with metastatic diseases not confirmed by pathology or cytology should obtain clear evidence of metastasis through physical examination or radiological research;
- Based on the pathological report of recent biopsy or other pathological specimens (confirmed by the laboratory of the participating research center), the histology and/or cytology are confirmed as triple negative breast cancer. The specific requirements include: a) the definition of negative human epidermal growth factor receptor 2(HER2): the immunohistochemistry (IHC) is 0 or 1+; If IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH). B) Negative estrogen and progesterone receptors means that IHC examination shows ER < 10% and or PR < 10%, and the researcher evaluates that patients cannot benefit from endocrine therapy.
- Newly diagnosed brain metastases or brain metastases that have progressed after local treatment: patients with brain metastases who met all the criteria of this scheme before starting from September 1, 2023 and did not meet all the exclusion criteria can also be included;
- Patients must have measurable central nervous system diseases, defined as at least one brain parenchymal lesion, which can be accurately measured in at least one dimension through local radiological examination; And there is no central nervous system symptom or symptom controllable, so radiotherapy is not needed urgently.
- Patients who have previously received at least one taxane and/or one anthracycline antibiotic (as a treatment history of neoadjuvant therapy, adjuvant therapy or metastatic therapy or both);
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- Allow (new) adjuvant therapy to have recurrence and metastasis after stopping using Utterone and/or Capecitabine for more than one year, or stop taking drugs for non-progressive reasons in the rescue stage;
- The physical status score (ECOGPS) of the eastern cancer cooperative group is 0-2, and the life expectancy is more than 12 weeks;
- Normal organ and bone marrow function; Blood routine examination was basically normal within one week before joining the group (based on the normal laboratory of each research center): neutrophil count (ANC) ≥ 1.5× 109/L; Hemoglobin (HB) ≥ 90g/L; Platelet count (PLT) ≥ 75× 109/L; Liver and kidney function tests were basically normal within one week before enrollment (based on the normal values of laboratories in each research center): total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (SGPT/ALT)≤2.5×ULN (patients with liver metastasis ≤ 5 XULN); Aspartate aminotransferase (SGOT/AST)≤2.5× upper limit of normal value (ULN); Creatinine clearance rate (Ccr)≥60ml/min.
- Neuropathy should be < grade 2 within 4 weeks before enrollment (version 5.0 of ncictcae);
- No major organ dysfunction and no heart disease;
- Women and male patients with reproductive potential must agree to use appropriate contraceptive measures before the start of the study and during the study participation.
Who cannot join
- Patients with extensive meningeal metastasis and brain metastasis who are ineffective in dehydration treatment with hormones or in urgent need of radiotherapy;
- Invasive breast cancer confirmed by histological or cytological examination, accompanied by metastatic disease; Patients with metastatic diseases not confirmed by pathology or cytology should obtain clear evidence of metastasis through physical examination or radiological research;
- Received chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before joining the group (the interval between targeted therapy and immunotherapy is at least 2 weeks or at least 5 half-lives, whichever is shorter); Received endocrine therapy within 1 week before joining the group; He had received nitrosourea or mitomycin chemotherapy within 6 weeks before joining the group;
- Receive unlisted clinical trial drugs within 4 weeks before entering the group;
- Previous history of grade 3 or 4 allergic reactions related to Utterone or Capecitabine;
- inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the taking and absorption of drugs;
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- Known contraindications for gadolinium MRI contrast agents, such as pacemakers, shrapnel or ocular foreign bodies;
- Suffering from other malignant tumors in the past 3 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of skin, squamous cell carcinoma of skin or early thyroid carcinoma;
- Seizures occurred more than 2 times within 4 weeks before joining the group;
- Poor control of hypertension; Or have a history of hypertensive crisis or hypertensive encephalopathy;
- Have a history of bleeding in the central nervous system of grade 3 or above within 12 months;
- Suffering from serious or uncontrollable diseases, including but not limited to: 1) active virus infection, such as HIV and HBV active phase (HbsAg positive and HBV-DNA≥103, hepatitis C antibody positive); 2) Suffering from severe cardiovascular disease in the past: uncontrollable hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. According to NYHA criteria, patients with grade Ⅲ ~ Ⅳ cardiac insufficiency, or those with left ventricular ejection fraction (LVEF) less than 50% indicated by echocardiography; 12. Suffering from serious or uncontrollable diseases, including but not limited to: 1) active virus infection, such as HIV and HBV active phase (HbsAg positive and HBV-DNA≥103, hepatitis C antibody positive); 2) Suffering from severe cardiovascular disease in the past: uncontrollable hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. According to NYHA criteria, patients with grade Ⅲ ~ Ⅳ cardiac insufficiency, or those with left ventricular ejection fraction (LVEF) less than 50% indicated by echocardiography;
- Have a history of hemoptysis within 6 months before joining the group; Or evidence of bleeding tendency or obvious coagulation dysfunction in the last month;
- Currently receiving full-dose warfarin or equivalent drugs, or taking aspirin (325mg/ day) within 10 days; 15.28 days or in the course of the study, it is expected that major surgery, open biopsy or major trauma are needed;
- 16. Those who have a history of abdominal fistula or gastrointestinal perforation in the first 6 months; There are unhealed wounds, active ulcers or untreated fractures; Pregnant or lactating women; 17. Those who have a history of psychotropic substance abuse and cannot quit or patients with mental disorders; 18. According to the judgment of the researcher, there are other patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 19. Those who are known to have allergic history to the drug components of this scheme; Have a history of immunodeficiency, including HIV positive, HCV or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 20. The history of live attenuated vaccine inoculation within 28 days before the first study or the person who is expected to be vaccinated with live attenuated vaccine in the study; 21. Any situation that the researcher thinks is not suitable for 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, 1 recruiting
- Recruiting
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan
Min Yan, Doctor, +86 15713857388, ym200678@126.com
Min Yan, Doctor
About this study
Official title: A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined With Capecitabine in the Treatment of Active Brain Metastasis of Triple-negative Advanced Breast Cancer.
This study aims to explore the efficacy and safety of the combination therapy of utidelone and capecitabine in the treatment of brain metastases from triple-negative advanced breast cancer, and to search for systemic treatment for brain metastases from triple-negative advanced breast cancer cases.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Utidelone and capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone and capecitabineDrug
Utidelone: intravenous capecitabine: oral
| Study group | Role | What they receive |
|---|---|---|
| One arm involving utidelone and capecitabine | Experimental | Combination use of utidelone and capecitabine Utidelone 30 mg/m2 d1-5(single-day dose allowed ± 10% fluctuation) , once every three weeks; capecitabine: 1000 mg/m2, twice daily, orally after meal (one in the morning and one in the evening, with an interval of about 12 hours, equivalent to a daily dose of 2000 mg/m2) ; The drug was administered consecutively on days 1-14, with a 21-day cycle. Receives: Drug: Utidelone and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS-ORR（RANO Standard）
CNS-ORR（RANO Standard）
Measured: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months.
Secondary outcomes (2)
CNS-ORR (RECIST1.1 standard)
CNS-ORR (RECIST1.1 standard)
Measured: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months.
CNS-PFS assessed by the investigator
CNS-PFS assessed by the investigator
Measured: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Jun 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
- Investigators
- Min Yan, Doctor, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598046
- Sponsor's protocol ID
- HNCH-MBC15-BM06
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined With Capecitabine in the Treatment of Active Brain Metastasis of Triple-negative Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT06598046
- Acronym / sponsor ID
- HNCH-MBC15-BM06
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (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 aims to explore the efficacy and safety of the combination therapy of utidelone and capecitabine in the treatment of brain metastases from triple-negative advanced breast cancer, and to search for systemic treatment for brain metastases from triple-negative advanced breast cancer cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm involving utidelone and capecitabine | Experimental | Drug: Utidelone and capecitabineCombination use of utidelone and capecitabine Utidelone 30 mg/m2 d1-5(single-day dose allowed ± 10% fluctuation) , once every three weeks; capecitabine: 1000 mg/m2, twice daily, orally after meal (one in the morning and one in the evening, with an interval of about 12 hours, equivalent to a daily dose of 2000 mg/m2) ; The drug was administered consecutively on days 1-14, with a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old;
- Invasive breast cancer confirmed by histological or cytological examination, accompanied by metastatic disease; Patients with metastatic diseases not confirmed by pathology or cytology should obtain clear evidence of metastasis through physical examination or radiological research;
- Based on the pathological report of recent biopsy or other pathological specimens (confirmed by the laboratory of the participating research center), the histology and/or cytology are confirmed as triple negative breast cancer. The specific requirements include: a) the definition of negative human epidermal growth factor receptor 2(HER2): the immunohistochemistry (IHC) is 0 or 1+; If IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH). B) Negative estrogen and progesterone receptors means that IHC examination shows ER < 10% and or PR < 10%, and the researcher evaluates that patients cannot benefit from endocrine therapy.
- Newly diagnosed brain metastases or brain metastases that have progressed after local treatment: patients with brain metastases who met all the criteria of this scheme before starting from September 1, 2023 and did not meet all the exclusion criteria can also be included;
- Patients must have measurable central nervous system diseases, defined as at least one brain parenchymal lesion, which can be accurately measured in at least one dimension through local radiological examination; And there is no central nervous system symptom or symptom controllable, so radiotherapy is not needed urgently.
Key exclusion criteria (15 listed)
- Patients with extensive meningeal metastasis and brain metastasis who are ineffective in dehydration treatment with hormones or in urgent need of radiotherapy;
- Invasive breast cancer confirmed by histological or cytological examination, accompanied by metastatic disease; Patients with metastatic diseases not confirmed by pathology or cytology should obtain clear evidence of metastasis through physical examination or radiological research;
- Received chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before joining the group (the interval between targeted therapy and immunotherapy is at least 2 weeks or at least 5 half-lives, whichever is shorter); Received endocrine therapy within 1 week before joining the group; He had received nitrosourea or mitomycin chemotherapy within 6 weeks before joining the group;
- Receive unlisted clinical trial drugs within 4 weeks before entering the group;
- Previous history of grade 3 or 4 allergic reactions related to Utterone or Capecitabine;
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 and capecitabineUtidelone: intravenous capecitabine: oral | Drug | One arm involving utidelone and capecitabine |
Primary outcome
CNS-ORR（RANO Standard）
Time frame: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months.
CNS-ORR（RANO Standard）
2 secondary outcomes
CNS-ORR (RECIST1.1 standard)
Time frame: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months.
CNS-PFS assessed by the investigator
Time frame: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 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 13 Oct 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.
Min Yan, Doctor principal investigator
Henan Cancer Hospital
1 site 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 capecitabine in people with Metastatic Breast Cancer, run by Henan Cancer Hospital 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 15 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 13 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.
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 Min Yan, Doctor (+8615713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS-ORR（RANO Standard） (time frame: From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 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 13 Oct 2026.