Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Tr… (NCT05552001) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
France96 participantsStarted 2023-10-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must have signed a written informed consent prior to any trial specific procedures;
. Male or female ≥ 18 years of age;
. 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 curative intent, whatever comes last.
. Prior exposure to a taxane
. Measurable disease, as defined by RECIST v1.1
. Patient must have accepted to perform on-treatment biopsies. If the physician considers doing the biopsy on the primary tumor site because accessibility, it can be performed only if the primary tumor site has not been previously irradiated;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: From inclusion to disease progression, up to 6 months
. Have metastatic site easily accessible to biopsy (with exception of bone metastasis)
. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
Exclusion criteria
. Participation in another therapeutic trial within the 30 days prior to C1D1;
. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases or evidence of leptomeningeal disease or clinically active spinal cord compression. Patients with stable and asymptomatic brain metastases will be eligible, yet the number will be capped to 15% of the overall population;
. Previous history of cancer other than mTNBC within 5 years prior to C1D1, except of those with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%) and treated with curative intent (e.g. carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);
. Prior treatment with topoisomerase-1 inhibitor or with ADC containing topoisomerase-1 inhibitor
. Met any of the following criteria for cardiac disease:
. Myocardial infarction or unstable angina pectoris within 6 months of enrolment.
. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \<40%.