NCT05535413 UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
| NCT ID | NCT05535413 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hunan Cancer Hospital |
| Condition | Metastatic HER2 Negative Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-01-01 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05535413 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Metastatic HER2 Negative Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05535413 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05535413 currently recruiting?
Yes, NCT05535413 is actively recruiting participants. Contact the research team at oyqc1969@126.com for enrollment information.
Where is the NCT05535413 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05535413 clinical trial?
NCT05535413 is sponsored by Hunan Cancer Hospital. The trial plans to enroll 30 participants.