A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib and Tislelizumab in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Cohort A Subjects will receive 70mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Cohort B Subjects will receive 100mg sitravatinib in combination with 200mg tislelizumab until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.Masking: None (Open Label)Masking Description: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This is a prospective, single-arm, single-center, two cohorts, Simon's two-stage design, phase II clinical trial in advanced triple-negative breast cancer patients. Subjects will be divided into two cohorts by different treatment dose of sitravatinib. Cohort A patients will receive 70mg sitravatinib...
This is a prospective, single-arm, single-center, two cohorts, Simon's two-stage design, phase II clinical trial in advanced triple-negative breast cancer patients. Subjects will be divided into two cohorts by different treatment dose of sitravatinib. 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). Subjects in both cohorts will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.
Tracking Information
- NCT #
- NCT04734262
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zhimin Shao, MD, PhD Fudan University
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