The goal of this study is to learn more about the effectiveness of the study drug, sacituzumab govitecan-hziy, in Chinese participants with metastatic triple-negative breast cancer (mTNBC) who received at least 2 systemic chemotherapy regimens.
This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan-hziy in locally advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer, and these regimens will qualify regardless of triple-negative status at the time they were given. The primary endpoint of the trial will be the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Review Committee (IRC) in all treated patients. Participants will be treated until progression requiring discontinuation of further treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor response and progression will be assessed using RECIST v 1.1 and assessment by Investigator at the trial center will be sufficient for decisions on continuation of treatment. An independent analysis of response will also be performed by IRC, but this will not be used to make treatment decisions. All participants will visit the Investigator at regular intervals for assessment of safety parameters and adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Administered intravenously
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Time frame: Up to 3 years
Duration of Response (DOR) by IRC
DOR is defined as the time between the date until the earlier date of disease progression or death.
Time frame: Up to 3 years
Clinical Benefit Rate (CBR)
CBR is defined as best overall response of CR or PR or stable disease (SD) of at least 6 months.
Time frame: Up to 3 years
Progression-free Survival (PFS)
PFS is defined as the time since the first dose of trial treatment until the earlier date of disease progression as defined by RECIST v1.1 or death due to any cause.
Time frame: Up to 3 years
Overall survival (OS)
OS is defined as the time since the first dose of trial treatment until death due to any cause.
Time frame: Up to 3 years
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: First dose date up to 3 years plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0
Time frame: First dose date up to 3 years plus 30 days
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Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Chinese PLA General Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Sun Yat-sen University, Cancer Center
Guangzhou, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
...and 7 more locations
Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38
Cmax is defined as the maximum observed concentration of drug.
Time frame: Up to 3 years
Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against Sacituzumab Govitecan-hziy
Time frame: Up to 3 years