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. 2021 Mar 29;17(1):63–70. doi: 10.1159/000514860

Table 1.

Characteristics of the clinical trials (ClinicalTrials.gov)

Study Type of study Drug Status Patients, n Population
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

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

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

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

NCT03032107 Phase Ib study Pembrolizumab combined with trastuzumab emtansine Recruiting Estimated 27 Metastatic breast cancer

NCT03125928 Single-arm phase IIA open label study Atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab Recruiting Estimated 50 HER2-positive metastatic breast cancer

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

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

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)

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

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

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

NCT03523572 Phase Ib, nonrandomized, dose escalation study Trastuzumab deruxtecan with nivolumab Recruiting 99 HER2-positive metastatic breast cancer, bladder cancer

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