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.
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