ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug.
ISIDE is a European, multicenter, open label, single-arm phase IIIB trial that aims to include 38 patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed on (neo)adjuvant chemotherapy with or without immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last. The primary objective is to to evaluate the efficacy of sacituzumab govitecan via investigator-assessed objective response rate (ORR) according to RECIST v1.1. Patient will receive SG until disease progression, unacceptable toxicity, or decision to withdraw its participation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Sacituzumab Govitecan (SG) is given by intervenous route, 10 mg/kg on day 1 and day 8 of 21-day treatment cycles. Patient will receive treatment until disease progression, unacceptable toxicity, or decision to withdraw its participation.
Gustave Roussy
Villejuif, France
RECRUITINGObjective response rate (ORR)
ORR is defined as the number of patient with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment
Time frame: From inclusion to disease progression, up to 6 months
Progression-free survival (PFS)
PFS iis the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Time frame: From inclusion to disease progression or death, up to 2 years
Duration of response (DOR)
DOR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression or death due to any cause
Time frame: From inclusion to disease progression or death, up to 2 years
Clinical benefice risk (CBR)
CBR is defined as the presence of at least a PR or CR, or a stable disease (SD) while on treatment
Time frame: From inclusion to disease progression or death, up to 2 years
Overall Survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Time frame: From inclusion to disease progression or death, up to 2 years
The incidence of adverse events (Safety)
Safety and tolerability of sacituzumab govitecan will be evaluated using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5). NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Time frame: Throughout study completion, up to 36 months
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