B002 in Patients With HER2-positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Recurrent Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Test staging: Phase I Design Type: Single Arm Test This study was a preliminary study of stage Ia, openness, dose escalation, pharmacokinetics, and efficacy. To assess safety and tolerability in HER2-positive recurrent or metastatic breast cancer subjects, to determine dose-limiting toxicity (DLT) and to explore maximum tolerated dose (MTD); to evaluate pharmacokinetic characteristics, immunization Originality and preliminary exploration of efficacy. The study was divided into the main trial period and the extended trial period. The subject trial completed the enrollment and DLT observations of all evaluable DLT subjects for the dose climbing phase; the PK expansion phase completed the enrollment required PK sample collection for the enrolled subjects. The extension test is the completion of the subject test and the subject continues to take the drug to the stage of progression of the disease or intolerance. Blind method: open Test range: Domestic testMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04382352
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Xichun Hu Cancer Hospital affiliated to Fudan University
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