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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
UTD1 combined with capecitabine
DrugUTD1: 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: UDT1 combined with capecitabineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CNS-Objective Response Rate (ORR)
The proportion of patients with complete remission (CR) and partial remission (PR) as the best efficacy evaluation in the total number of evaluable patients observed during the process from enrollment to the progression of all CNS target lesions assessed according to the RANOBM criteria.
Time frame
From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.Secondary outcomes
1
CNS clinical benefit rate (CNS-CBR)
The percentage of patients who achieved complete response (CR), partial response (PR) or disease stability (SD) as the best efficacy evaluation in the total number of evaluable patients observed from enrollment to all CNS target lesions assessed according to the RANOBM criteria.
Time frame
From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.2
CNS progression free survival (CNS-PFS)
The time from enrollment to the first imaging confirmed disease progression (PD) of all central nervous system target lesions (RANOBM criteria) or death due to any cause without progression recorded.
Time frame
From enrollment to the first imaging confirmed disease progression (PD) of all central nervous system target lesions (RANOBM criteria) or death due to any cause without progression recorded up to 1 year.3
CNS objective response rate (CNS-ORR)
The proportion of patients with complete remission (CR) and partial remission (PR) as the best efficacy evaluation in the total number of evaluable patients observed during the process from enrollment to the progression of all CNS target lesions assessed according to the RECIST 1.1 criteria.
Time frame
From the enrollment to the progression of all CNS target lesions assessed according to RECIST 1.1 standard up to 1 year.4
Objective response rate (ORR)
According to RECIST 1.1 criteria, the number of patients with the best efficacy evaluation of CR or PR during the process from enrollment to disease progression accounts for the proportion of the total number of evaluable patients.
Time frame
From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.Sponsors and contacts
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Source ClinicalTrials.gov