Sacituzumab Tirumotecan Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR
Recruiting
Trial purpose
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (sac-TMT; MK-2870) in combination with pembrolizumab compared to treatment of physician’s choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sac-TMT plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesised that sac-TMT plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
View full trial information on Clinicaltrials.govNATIONAL TRIAL REFERENCE NUMBER
NCT06393374
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Eligibility
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Conditions
Triple-Negative Breast Cancer
Age Range
18+
Sex
Male/Female
Study Details
Current trial Phase
Phase 3
Tests the medicine or vaccine in approximately 1,000 to 5,000 participants. For medicines, participants have the disease or condition the medicine is designed to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date 06-24-2024
- Estimated primary completion date 12-16-2030
- Estimated trial completion date 12-14-2037
Trial Locations
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