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

NCT05552001 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sacituzumab govitecan

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.

Sponsors & Collaborators

Principal Investigators

  • Barbara Pistilli, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2026-05-01
Completion
2028-05-06

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552001 on ClinicalTrials.gov