Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC
ConditionTriple -Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorXijing Hospital
About this trial
To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.
Eligibility criteria
Qualifiers
Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.
ECOG Performance Status: 0-1.
Life Expectancy: Estimated survival of not less than 3 months.
Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
Disqualifiers
Patients with metastatic breast cancer (Stage IV).
Baseline left ventricular ejection fraction (LVEF) <50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.
Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.
Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.
Trial design
Treatments tested in this trial
- Sacituzumab Tirumotecan
Treatment groups
35 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov