Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
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
UNICANCER
96 participants
Oct 5, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Locations(1)
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NCT05552001