UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHunan Cancer Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- UTD1 combined with capecitabine
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Quchang Ouyang410000, Changsha China
Sponsors and collaborators
Hunan Cancer Hospital
Lead sponsor
Source ClinicalTrials.gov