Combining UTD1 and Capecitabine for HER2-negative Breast Cancer with Brain Metastases
A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
This study is testing if a new treatment combining UTD1 and Capecitabine can help people with HER2-negative breast cancer that has spread to the brain.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Hunan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Changsha) |
| Trial ID | NCT05535413 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of UTD1 in combination with Capecitabine for patients suffering from metastatic HER2-negative breast cancer that has spread to the brain. It is a single-arm, multicenter, open-label study, meaning all participants will receive the same treatment without a control group. The study focuses on patients who have measurable brain lesions and aims to determine how well this combination therapy works in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with confirmed HER2-negative metastatic breast cancer and measurable brain lesions.
Not a fit: Patients with rapidly progressing brain metastases requiring immediate local treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with challenging brain metastases from HER2-negative breast cancer.
How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with chemotherapy have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients aged 18 to 70 years
* With histologically confirmed HER2 negative recurrent and metastatic breast cancer
* have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm)
* ECOG score (PS) of 0-2
* According to screening brain MRI, patients with CNS must meet the following conditions:
1. untreated brain metastases of breast cancer;
2. do not need immediate local treatment;
3. brain metastases of breast cancer which was treated in the past:
1. There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment.
2. All records related to the treatment of the central nervous system must be provided.
3. All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level 1 (CTCAE v50). However, patients with hair loss of any grade are allowed to be recruited.
* Blood routine examination was basically normal within 1 week before enrollment.
* White blood cell count (WBC) ≥ 30 × 109 /L
* Neutrophil counts (ANC) ≥ 15 × 109/L
* Platelet count (PLT) ≥ 100 × 109 /L
* Hemoglobin ≥ 90g/dl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.
* Within 1 week before enrollment, the liver and kidney function tests were basically normal (based on the normal value of the laboratory of each research center).
* Total bilirubin ≤ 15 × Upper limit of normal value (ULN)
* Alanine aminotransferase (SGPT / ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)
* Glutamic oxaloacetic transaminase (SGOT/AST) ≤ 25 × ULN (patients with liver metastasis ≤ 5 × ULN)
* Creatinine clearance rate (Ccr) ≥ 60ml/min patients
* With fertility must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication. Before enrollment, the blood or urine pregnancy test must be negative and the
* Life expectancy \> 12 weeks.
* The patient must be able to participate in and follow the treatment and follow-up.
Exclusion Criteria:
* Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)
* Other malignant carcinomas (including primary brain or leptomeningeal related tumors) in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
* Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine.
* Patients who have received surgical operation on major organs (excluding puncture biopsy) or have suffered significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial.
* Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above.
* Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment \< 3 months) or unable to tolerate to capecitabine.
* For any brain lesions requiring immediate local treatment, such as increased lesion size or treatment-related edema at intracranial (but not limited to) anatomical sites may pose risks to patients (e.g., brainstem lesions)
* Known or suspected leptomeningeal disease (LMD)
* Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that are excluded from any treatment regimen or interfere with follow-up in pregnant or lactating women.
* Known or suspected allergy to any study drug or accessories.
* Brain MRI can not be performed for any other reason.
* The investigator considers it inappropriate to participate in.
* Other situations where corticosteroids are prohibited.
Where this trial is running
Changsha
- Quchang Ouyang — Changsha, China (Recruiting)
Study contacts
- Study coordinator: Quchang Ouyang
- Email: oyqc1969@126.com
- Phone: +8673189762161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.