At a glance
ClinicalIndex Comparison Record- ✓Centrally confirmed TNBC per ASCO/CAP guidelines
- ✓No evidence of locoregional or distant relapse
- ✓Prior neoadjuvant KEYNOTE-522 regimen (pembrolizumab + carboplatin/taxanes or anthracycline chemotherapy) followed by surgery
- ✓Non-pathologic complete response at surgery
- ✕Known BRCA mutation (deleterious or suspected deleterious) eligible for olaparib where approved and available
- ✕Grade >2 peripheral neuropathy
- ✕Severe dry eye syndrome, Meibomian gland disease, blepharitis, or corneal disease preventing healing
- ✕Active inflammatory bowel disease requiring immunosuppression or prior IBD history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus 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
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Sacituzumab tirumotecan, and 1 other intervention for Triple-Negative Breast Cancer. Currently recruiting, targeting 1,530 participants across 304 sites in 31 countries.
Signals
Detailed Summary
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (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 sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Study Details
Timeline
Arms & Interventions
Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.
Interventions
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID