Table 1.
Study | Type of study | Drug | Status | Patients, n | Population |
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PANACEA NCT02129556 [16] | Single-arm phase Ib/II study | Experimental: MK-3475 (pembrolizumab) with trastuzumab (single arm) Phase Ib: MK-3475 at a dose of 2 or 10 mg/kg (i.v.), or a fall-back dose of 1 mg/kg, together with trastuzumab at 6 mg/kg (i.v.) once every 3 weeks Phase II: MK-3475 at a flat dose of 200 mg (i.v.) together with trastuzumab at 6 mg/kg (i.v.) once every 3 weeks until progression, lack of tolerability, or 24 months of treatment A dose of 8 mg/kg trastuzumab will be used in cycle 1 if prior treatment with trastuzumab has been stopped more than 3 months prior |
Recruitment completed | 58 | Metastatic Breast cancer, central nervous system after local treatment included |
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AVIATOR study NCT03414658 | Randomized phase II open label trial | Trastuzumab and vinorelbine with avelumab or avelumab and utomilumab in advanced HER2+ breast cancer | Recruiting | Estimated 100 | Patients with HER2-positive metastatic breast cancer who have progressed on prior trastuzumab and pertuzumab |
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NCT02649686 [21] | Randomized phase Ib/II study | Durvalumab plus trastuzumab Durvalumab q3w until PD trastuzumab q3w ×6 | Active, not recruiting | 15 | HER2-positive metastatic breast cancer |
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NCT02403271 | Phase Ib/II multicenter study | Ibrutinib in combination with durvalumab (MEDI4736) in subjects with relapsed or refractory solid tumors | Completed | 124 | Non-small cell lung cancer breast cancer Pancreatic cancer |
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NCT03032107 | Phase Ib study | Pembrolizumab combined with trastuzumab emtansine | Recruiting | Estimated 27 | Metastatic breast cancer |
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NCT03125928 | Single-arm phase IIA open label study | Atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab | Recruiting | Estimated 50 | HER2-positive metastatic breast cancer |
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NCT02605915 | Nonrandomized phase Ib study | Atezolizumab in combination with trastuzumab emtansine or with trastuzumab and pertuzumab (with and without docetaxel) in patients with HER2-positive breast cancer and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer | Active, not recruiting | Estimated 98 | Metastatic breast cancer |
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NCT03417544 | Single-arm phase II study | Atezolizumab in combination with pertuzumab plus high-dose trastuzumab | Recruiting | Estimated 33 | HER2-positive metastatic breast cancer Central nervous system metastases |
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NCT03595592 | Randomized phase III interventional clinical trial | Atezolizumab, pertuzumab, and trastuzumab with chemotherapy as neoadjuvant treatment | Not yet recruiting | Estimated 650 | Neoadjuvant HER2-positive early high-risk and locally advanced breast cancer (APTneo) |
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NCT02924883 | Randomized, multicenter, double-blind, placebo-controlled phase II trial | Trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo | Active, not recruiting | Estimated 202 | HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab and taxane-based therapy |
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NCT03650348 | Phase Ib open-label, dose escalation study | PRS-343 in combination with atezolizumab | Recruiting | Estimated 70 | HER2-positive advanced or metastatic solid tumors Breast, gastric, bladder, and solid tumors |
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NCT03199885 | Randomized, double-blind phase III trial | Paclitaxel/trastuzumab/pertuzumab with atezolizumab or placebo | Not yet recruiting | Estimated 600 | First-line HER2-positive metastatic breast cancer |
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NCT03523572 | Phase Ib, nonrandomized, dose escalation study | Trastuzumab deruxtecan with nivolumab | Recruiting | 99 | HER2-positive metastatic breast cancer, bladder cancer |
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NCT03726879 | Randomized, double-blind phaseIII trial | Atezolizumab or placebo in combination with neoadjuvant doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab | Recruiting | 453 | Early HER2-positive breast cancer |