Table 3.
Ongoing combinations trials with immune checkpoint inhibitors and the novel anti-HER2 agents in HER2-low breast cancer.
| Drugs Tested | Study Design | Patient Population | Primary Endpoint | Status | ClinicalTrials.gov Identifier |
|---|---|---|---|---|---|
| Trastuzumab–deruxtecan + pembrolizumab | Phase Ib, open-label, two-part, multicenter, nonrandomized, multiple-dose | Advanced BC (HER2-positive and HER2-low) and HER2-positive NSCLC | Phase I: MTD Phase II: ORR |
Recruiting | NCT04042701 |
| Trastuzumab–deruxtecan + nivolumab | Phase Ib, multicenter, two-part, open-label | Advanced BC (HER2-positive and HER2-low) and urothelial cancer | Phase I: MTD Phase II: ORR |
Ongoing | NCT03523572 |
| Trastuzumab–deruxtecan + durvalumab | Phase Ib/II, two-stage, open-label, multicenter | Arm 6: Advanced TNBC with low HER2 expression | Safety | Recruiting | NCT03742102 |
| Trastuzumab–deruxtecan + durvalumab + paclitaxel | Phase Ib, open-label, modular, dose-finding and dose-expansion | Module 2: advanced HER2-low BC | Safety and tolerability | Not yet recruiting | NCT04556773 |
Legend: BC: breast cancer; ET: endocrine therapy; NSCLC: non-small cell lung cancer; MTD: maximum tolerated dose; ORR: objective response rate; TNBC: triple-negative breast cancer.