Leflunomide in Previously Treated Metastatic Triple Negative Cancers
Status:
Recruiting
Trial end date:
2021-10-20
Target enrollment:
Participant gender:
Summary
Triple negative breast cancer (TNBC) represents about 15% of breast cancers and is
characterized by the lack of expression of estrogen receptor (ER), progesterone receptor
(PR), and HER-2 non-amplification. Women with TNBC tend to be younger, African American, and
BRCA-1 germline carriers. The hallmark of this subtype is early metastatic recurrences with a
peak frequency 1-2 years. Prognosis for metastatic TNBC is especially poor with median
survival of about 1 year as compared to about 2-4 years with other types of metastatic breast
cancer.
The primary objective of the phase I part of this study is to determine the safety,
tolerability and maximum tolerated dose of leflunomide in women with previously treated TNBC.
The primary objective of the phase 2 part of this study is to determine the efficacy of
leflunomide in patients with TNBC.
Leflunomide, which will be taken daily by mouth, is an inhibitor of dihydroorotate
dehydrogenase (DHODH). This proposal will test if DHODH is a novel target for a particular
subset of women with metastatic TNBC.