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

Source: https://onco.cc/trials/nct05552001/  
OnCo record `nct05552001` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of sacituzumab govitecan in triple-negative breast cancer, run by UNICANCER, active but no longer recruiting.

## Summary

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer is a phase 3, interventional study registered as NCT05552001 by UNICANCER, with a registry enrolment figure of 96 participants, started 2023-10-05 and due to reach its primary completion in 2026-10-01. Interventions recorded: Sacituzumab govitecan. Conditions listed: Triple Negative Breast Cancer; Metastatic Breast Cancer. Triple-negative eligibility wording from the registry: "Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose 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 cur". Sites: France. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: ISIdE
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: NCT05552001
- Phase: 3
- Setting: 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
- Sponsor: UNICANCER
- Enrolled: 96

## Sources

- ClinicalTrials.gov NCT05552001: https://clinicaltrials.gov/study/NCT05552001

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- drugs: [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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