OncoMatch/Clinical Trials/NCT05552001
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
Is NCT05552001 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Sacituzumab govitecan for triple negative breast cancer.
Treatment: Sacituzumab govitecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 0, 1+, or 2+ and FISH non-amplified)
absence of HER2 overexpression by immunohistochemistry (IHC) defined as IHC 0, 1+, or 2+ and fluorescence in situ hybridization [FISH] non-amplified
Required: ESR1 expression <10% (<10%)
estrogen receptor (ER) expression <10%
Required: PR (PGR) expression <10% (<10%)
progesterone receptor (PR) expression <10%
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — neoadjuvant or adjuvant
disease has progressed on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last
Must have received: taxane
Prior exposure to a taxane
Cannot have received: topoisomerase inhibitor
Prior treatment with topoisomerase-1 inhibitor or with ADC containing topoisomerase-1 inhibitor
Lab requirements
Blood counts
Adequate haematologic function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
No NYHA Class III or greater congestive heart failure or LVEF <40%; no recent MI or unstable angina; no serious ventricular arrhythmia or high-grade AV block; no history of QT prolongation
Adequate haematologic and organ function; Met any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrolment. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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