UNICANCER
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: evaluate the treatment efficacy in less pretreated patients. identify biomarkers that could predict response or resistance to the drug. 100 patients will be included in this trial.
Triple Negative Breast Cancer
Metastatic Breast Cancer
Sacituzumab govitecan
Phase 3
ISIDE is a European, multicenter, open label, single-arm phase IIIB trial that aims to include 100 patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed either on: 1st line chemotherapy with or without immune checkpoint inhibitors (ICIs) or targeted therapy (e.g. AKT inhibitor, PI3K inhibitor, PARP inhibitor) for metastatic or inoperable locally advanced breast cancer (ABC) (neo)adjuvant chemotherapy with or without immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last. The primary objective is to to evaluate the efficacy of sacituzumab govitecan via investigator-assessed objective response rate (ORR) according to RECIST v1.1. Patient will receive SG until disease progression, unacceptable toxicity, or decision to withdraw its participation.
Study Type : | Interventional |
Estimated Enrollment : | 96 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | October 5, 2023 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | May 1, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Single arm receiving sacituzumab govitecan |
Drug: Sacituzumab govitecan |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Gustave Roussy
Villejuif, France, 94800