A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
NCT ID: NCT06764940
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-07-14
2027-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer
NCT06458413
A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC
NCT06598046
Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases
NCT05357417
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer
NCT05052437
Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer
NCT02253459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
(stage 1) monotherapy group
Utidelone
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
(stage 1) combination group A
Utidelone in combination with capecitabine
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.
(stage 1) combination group B
Utidelone in combination with capecitabine
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.
(stage 2) combination group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Utidelone
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 capecitabine
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 capecitabine
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 capecitabine
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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) .
3. Male or female aged ≥18 years.
4. ECOG PS 0 or 1.
5. Have a life expectancy of at least 3 months.
6. Have adequate baseline hematologic parameters.
7. Have adequate hepatic and renal function.
8. ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
9. 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.
10. 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.
Exclusion Criteria
2. 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).
3. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
4. Had evidence of intracranial hemorrhage within 3 months before study treatment.
5. Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
6. Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment.
7. 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.
8. Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline.
9. Patients with neuropathy\> grade 1.
10. Known hypersensitivity to any components of the investigational product.
11. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
12. 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.
13. Patients who are pregnant (positive pregnancy test) or lactating.
14. 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.
15. 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).
16. 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.
17. With a history of severe or uncontrolled diseases.
18. Autoimmune diseases requiring treatment with systemic glucocorticoids.
19. Not able to perform contrast-enhanced brain MRI or known contraindications to MRI gadolinium contrast, such as cardiac pacemaker, shrapnel, or eye foreign body.
20. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biostar Pharma, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope--Duarte
Duarte, California, United States
Cancer & Blood Research Center, LLC
Los Alamitos, California, United States
Univ. of California Los Angeles
Los Angeles, California, United States
FOMAT Medical Research (Network)
Oxnard, California, United States
Scripps Health
San Diego, California, United States
University Of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Biosresearch Partner
Hialeah, Florida, United States
D&H Cancer Research Center
Margate, Florida, United States
Augusta University
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, United States
The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Profound Research LLC
Farmington Hills, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Community Clinical Trials
Kingwood, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BG01-2402
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.