The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.
This is a prospective, single-center, three cohorts, phase II clinical trial in locally recurrent or metastatic triple-negative breast cancer(TNBC) patients. Subjects will be divided into three cohorts by different treatment combination. Cohort A \& Cohort B aim to explore the two dosages of sitravatinib in combination with tislelizumab in TNBC with prior ≤ 3 treatment line. Cohort A patients will receive 70mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV); Cohort B patients will receive 100mg sitravatinib (QD PO) in combination with 200mg tislelizumab (Q3W IV). Cohort C aims to explore the sitravatinib (QD PO) plus 200mg tislelizumab (Q3W IV) and 100 mg/m2 nab-paclitaxel (D1, D8 Q3W IV) in TNBC previously untreated for metastatic setting or recurred/metastasized after surgery. Subjects in the three cohorts will be treated until disease progression, intolerable toxicity, informed consent withdrawn, or investigators-determined medication termination. Drug efficacy and safety data will be collected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Sitravatinib QD PO Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Tislelizumab Q3W IV Tislelizumab is a programmed death receptor-1 (PD-1) blocking antibody
Nab-paclitaxel D1, D8 Q3W IV Nab-paclitaxel is a chemotherapy drug which combines the chemotherapy drug paclitaxel with albumin
Fudan University Shanghai Cancer
Shanghai, Shanghai Municipality, China
Overall Response Rate (ORR) by Investigator in Cohort A, Cohort B and Cohort C
The number of people with tumor responses according to RECIST (V1.1): the proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR).
Time frame: Up to 12 months
Number of participants experiencing ≥ Grade 3 TRAEs in Cohort B
TRAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated.
Time frame: Up to 12 months
Duration of Response (DOR) by Investigator in Cohort A, Cohort B and Cohort C
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Time frame: Up to 12 months
Disease Control Rate (DCR) by Investigator in Cohort A, Cohort B and Cohort C
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Time frame: Up to 12 months
Progression-free Survival (PFS) by Investigator in Cohort A, Cohort B and Cohort C
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Time frame: Up to 12 months
One-year overall survival (OS) rate in Cohort A, Cohort B and Cohort C
OS defined as the time from the date of randomization to the date of death due to any reason. One-year survival rate (percentage of subjects alive at 1 year) was estimated from OS data.
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Time frame: Up to 12 months
Number of participants experiencing Adverse Events (AEs), Treatment-Related Adverse Events (TRAEs) or Serious Adverse Events (SAEs) in Cohort A, Cohort B and Cohort C
Adverse Events (AEs) according to CTCAE v5.0
Time frame: Up to 12 months
Patient report outcomes (PROs) based on the EORTC QLQ-C30 (V.3) Quality of Life Questionnaire in Cohort B and Cohort C
Evaluating the Quality of Life of participants as assessed by EORTC QLQ-C30 Questionnaire
Time frame: Through study completion, an average of 1 year
Potential biomarkers associated with efficacy, drug resistance, and/or disease progression (PD) in tumor tissues in Cohort A, Cohort B and Cohort C
Potential biomarkers in tumor tissues associated with efficacy
Time frame: Through study completion, an average of 1 year