Study design and participants
breast carcinoma, tumor, HER2-negative, Tumors, PR-negative, TNBCs
BREAST CARCINOMA, BRAIN METASTASIS, TUMOR, TUMORS, ONCOLOGY
FUTURE is a phase II, open-label, multicenter, umbrella trial evaluating the efficacy and safety of multiple precision treatments based on molecular subtype and tumor characteristics in patients with heavily pretreated metastatic TNBCs. Eligibility criteria included the following: (1) female patients diagnosed with metastatic breast carcinoma with an ER-negative, PR-negative, and HER2-negative phenotype (the IHC cutoff for ER/PR-negative status was less than 1% staining in nuclei, and HER2-negative status was defined as a score of 0 or 1 by IHC analysis or the absence of ERBB2 amplification by fluorescence in situ hybridization with an IHC score); (2) central pathologic examination of tumor specimens performed by the Department of Pathology at FUSCC; (3) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; (4) at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; and (5) adequate hematologic function, hepatic function, and renal function. Patients with uncontrolled brain metastasis were excluded from enrollment. Full eligibility criteria are provided in the study protocol in Supplementary information, Data The trial was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. The study protocol was approved by the institutional review board and ethics committee of FUSCC. The ethics committee reference number was 1807188-16. All patients provided written informed consent to participate in this study.