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Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer — ISIdE  

Metastatic Breast Cancer Clinical Trial

Official title:
ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis

Clinical Trial Summary

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. 100 patients will be included in this trial.

Clinical Trial Description

ISIDE is a European, multicenter, open label, single-arm phase IIIB trial that aims to include 100 patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed either on: - 1st line chemotherapy with or without immune checkpoint inhibitors (ICIs) or targeted therapy (e.g. AKT inhibitor, PI3K inhibitor, PARP inhibitor) for metastatic or inoperable locally advanced breast cancer (ABC) - (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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552001
Study type Interventional
Source UNICANCER
Contact Clara GUYONNEAU, PharmD
Phone 0685167111
Email c-guyonneau@unicancer.fr
Status Recruiting
Phase Phase 3
Start date October 5, 2023
Completion date May 1, 2026
View Details
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