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

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer Metastatic Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
UNICANCER · Other
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About This Trial
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 re…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient must have signed a written informed consent prior to any trial specific procedures; Note: When the patient is unable to write to give his written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing th…
Contacts

Clara GUYONNEAU, PharmD

0685167111

c-guyonneau@unicancer.fr

CONTACT