NCT06764940 · Biostar Pharma, Inc.
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
What this study is about
This study is a conducted at multiple hospitals, two-stage clinical trial to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Utidelone
Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
DRUG
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.
DRUG
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.
DRUG
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.
Primary outcome measures
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Time frame: 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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). (According to the 2023 American Society of Clinical Oncology \[ASCO\]/ College of American Pathologists \[CAP\] guidelines). 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) and must have one of the following: A) Untreated brain metastases not needing immediate local therapy. B) Brain metastases progressing after prior local therapy. 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 o
Where
- Duarte, California
- Los Alamitos, California
- Los Angeles, California
- Oxnard, California
- San Diego, California
- Aurora, Colorado
- Hialeah, Florida
- Margate, Florida
- Augusta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Farmington Hills, Michigan
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations