Study design and patient population
TNBC, mTNBC
ONCOLOGY, DISEASE, IMMUNODEFICIENCY
This open-label single institutional phase I trial for patients with metastatic TNBC was conducted between March 2016 and November 2019 with institutional review board (IRB) approval in accordance with the World Medical Association Declaration of Helsinki, International Conference on Harmonization Good Clinical Practice guidelines, and the US code of federal regulations. Informed voluntary consent forms were signed by all patients prior to study entry. This study is registered at the ClinicalTrials.gov under number NCT02648477. Main eligibility criteria included patients who were 18 years or older with mTNBC defined by ASCO/CAP guideline, no prior anthracycline exposure, measurable disease based on RECIST 1.1, and ≤ 2 prior systemic anticancer therapies in the metastatic setting. Additional inclusion criteria were an Eastern Cooperative Oncology Group (ECOG) performance status 0–1; life expectancy ≥ 3 months; and adequate bone marrow, renal, and hepatic function. Main exclusion criteria included prior anthracycline therapy; prior pembrolizumab therapy; or prior diagnosis of immunodeficiency, use of systemic steroid, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.