The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Trastuzumab Rezetecan 4.8mg/kg, IV, Day 1, Q3W
Chemotherapy of Physician's Choice, including nab-paclitaxel, Eribulin, Capecitabine
Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
Time frame: From the start of treatment to 36 month
Clinical Benefit Response (CBR)
CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1. The CBR will be reported by percentage with each arms and appropriate confidence intervals.
Time frame: From the start of treatment to 36 month
Objective Overall Response Rate (ORR)
ORR is defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Time frame: From the start of treatment to 36 month
Overall Survival (OS)
Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death. The OS will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.
Time frame: From the start of treatment to 36 month
Adverse events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. The type, grade and frequency of AEs will be reported.
Time frame: From the start of treatment to 36 month
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