Actively Recruiting
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
Led by UNICANCER · Updated on 2025-06-11
96
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent prior to any trial procedures
- Male or female aged 18 years or older
- Pathologically confirmed locally advanced inoperable or metastatic triple-negative breast cancer with disease progression after (neo)adjuvant chemotherapy with or without immunotherapy or within 6 months after last systemic therapy, surgery, or radiotherapy with curative intent
- Prior exposure to a taxane; prior immune checkpoint inhibitor therapy required if PD1 positive tumor; prior PARP inhibitor required if germline BRCA mutated
- Measurable disease per RECIST v1.1
- Agreement to perform on-treatment biopsies; biopsy of primary tumor allowed only if not previously irradiated
- Metastatic site accessible for biopsy, except bone metastasis; patients with only bone metastasis eligible if primary tumor accessible for biopsy
- ECOG performance status 0 to 2
- Life expectancy of at least 12 weeks
- Adequate hematologic and organ function
- Negative hepatitis B surface antigen test at screening or negative hepatitis C virus antibody or RNA test as specified
- Evidence of post-menopausal status or negative pregnancy test within specified time before treatment for pre-menopausal women
- Women of childbearing potential and male patients must agree to use adequate contraception during and after trial participation
- Affiliated to a social security system or equivalent
- Willing and able to comply with protocol including treatment, visits, and follow-up
You will not qualify if you...
- Participation in another therapeutic trial within 30 days before treatment
- Symptomatic, untreated, or active central nervous system metastases, leptomeningeal disease, or active spinal cord compression; stable asymptomatic brain metastases allowed up to 15% of participants
- History of other cancers within 5 years except low-risk cancers treated curatively
- Prior treatment with topoisomerase-1 inhibitors or antibody-drug conjugates containing them
- Recent serious cardiac disease including myocardial infarction, serious arrhythmias, or heart failure NYHA class III or above
- Severe uncontrolled infection requiring antibiotics within 4 weeks
- Major surgery within 4 weeks
- Severe allergic or hypersensitivity reactions to humanized antibodies
- Known hypersensitivity to study drug or its components
- Concurrent anti-cancer treatments such as chemotherapy, immunotherapy, endocrine therapy, or radiotherapy
- Unresolved toxicities from previous cancer therapy above grade 2 except alopecia
- Recent systemic corticosteroids or immunosuppressive therapy
- Known HIV infection not controlled
- Significant uncontrolled concomitant disease
- Need for prohibited or cautioned medications
- Physical or psychological conditions incompatible with trial participation
- Persons deprived of liberty or under protective custody
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with medical follow-up due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
C
Clara GUYONNEAU, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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