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New treatment option for HER2-negative Breast Cancer Patients With Brain Metastases
Official title A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
ClinicalTrials.gov ID: NCT06764940
What this study is testing
What is Utidelone?
Utidelone is an investigational medicine, given as an once-daily, being studied as a potential treatment for her2-negative breast cancer patients with brain metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+...
- 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...
- Male or female aged ≥18 years.
- ECOG PS 0 or 1.
- Have a life expectancy of at least 3 months.
You likely can't join if
- 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...
- Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases...
- 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.
See the full eligibility 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).
- 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.
- 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...
- 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.
- 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...
- 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.
- 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...
- 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...
- 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...
- Patients who are particpating in other treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Hialeah, Florida, United States
- Margate, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Farmington Hills, Michigan, United States
- Las Vegas, Nevada, United States
- Stony Brook, New York, United States
- Houston, Texas, United States
- Kingwood, Texas, United States
- Webster, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Oxnard, California, United States; San Diego, California, United States; Aurora, Colorado, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.