RecruitingPhase 1Phase 2NCT05535413

UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients 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


Sponsor

Hunan Cancer Hospital

Enrollment

30 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — UTD1 and capecitabine (an oral chemotherapy) — for patients with breast cancer that has spread to the brain. Brain metastases from breast cancer are difficult to treat and options are limited, so researchers are evaluating whether this combination can shrink brain tumors and improve quality of life. **You may be eligible if:** - You are between 18 and 70 years old - You have HER2-negative breast cancer that has spread (metastatic) - Your cancer has spread to the brain, with at least one measurable brain tumor (10 mm or larger) - Your general health status is good to moderate (ECOG score 0–2) - Your brain metastases are either untreated or previously treated but stable **You may NOT be eligible if:** - Your breast cancer is HER2-positive - Your brain metastases require urgent local treatment - You have significant side effects from prior treatments that haven't resolved - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUTD1 combined with capecitabine

UTD1: 30mg/m2/day, once a day, continuously from day 1 to day 5, 21 days as a treatment cycle. Capecitabine: 2000mg / m2 / day, continuously from day 1 to day 14, orally twice a day, 21 days as a treatment cycle.


Locations(1)

Quchang Ouyang

Changsha, China

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NCT05535413


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