Actively Recruiting
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
Led by Biostar Pharma, Inc. · Updated on 2025-11-28
120
Participants Needed
17
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed HER2-negative metastatic breast cancer (IHC score 0 or 1+, or IHC2+ with negative ISH).
- At least one measurable intracranial lesion (≥1.0 cm) on contrast-enhanced brain MRI.
- Male or female aged 18 years or older.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate baseline blood counts.
- Adequate liver and kidney function.
- Received no more than 3 prior lines of chemotherapy for advanced or metastatic disease.
- Women of childbearing potential must use effective contraception before and during study and for 6 months after; men or their partners must also use effective contraception during this period.
- Ability to comply with study visit schedule and provide informed consent.
You will not qualify if you...
- Leptomeningeal metastasis confirmed by MRI or cerebrospinal fluid cytology.
- Intracranial lesions requiring immediate local therapy or located in high-risk brain areas.
- Poorly controlled seizures or neurological progression despite CNS therapy.
- Intracranial hemorrhage within 3 months before treatment.
- Hemoptysis within 6 months or recent bleeding/coagulopathy.
- Major surgery within 4 weeks before treatment or not fully recovered.
- Received anti-tumor therapies within 2 weeks before first study dose.
- Unresolved toxicities from prior therapy above grade 1 (except alopecia).
- Neuropathy greater than grade 1.
- Known allergies to study drugs.
- Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Prior capecitabine treatment with progressive disease response or within 6 months before study (for combination group).
- Pregnancy or breastfeeding.
- Other active malignancies within 5 years except certain inactive tumors.
- Participation in other interventional studies or ongoing study treatments.
- Active or uncontrolled hepatitis B, syphilis, or HIV infections.
- History of severe or uncontrolled diseases.
- Autoimmune diseases needing systemic glucocorticoids.
- Unable to undergo contrast-enhanced brain MRI or contraindications to MRI contrast.
- Other severe systemic diseases or lab abnormalities judged unsuitable by investigator.
AI-Screening
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Trial Site Locations
Total: 17 locations
1
City of Hope--Duarte
Duarte, California, United States, 91010
Not Yet Recruiting
2
Cancer & Blood Research Center, LLC
Los Alamitos, California, United States, 90720
Actively Recruiting
3
Univ. of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
FOMAT Medical Research (Network)
Oxnard, California, United States, 93030
Actively Recruiting
5
Scripps Health
San Diego, California, United States, 92121
Actively Recruiting
6
University Of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Biosresearch Partner
Hialeah, Florida, United States, 33013
Actively Recruiting
8
D&H Cancer Research Center
Margate, Florida, United States, 33063
Actively Recruiting
9
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
10
Robert H. Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
11
The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
12
Profound Research LLC
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
13
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
14
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794-7263
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Community Clinical Trials
Kingwood, Texas, United States, 22751
Actively Recruiting
17
Tranquil Clinical Research
Webster, Texas, United States, 77598
Actively Recruiting
Research Team
S
Simon Guan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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