Leflunomide in Previously Treated Metastatic Triple Negative Cancers

Status Recruiting

Clinical Trial 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 (or ER+ , HER2-neg MBC in Phase I). 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Breast Diseases
Breast Neoplasms
Metastatic Triple Negative Breast Cancer
Triple Negative Breast Neoplasms

Clinical Trial Details

NCT number	NCT03709446
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Rita Vaccaro, RN
Phone	212-659-5549
Email	rita.vaccaro@mssm.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 16, 2019
Completion date	October 2026

View Details

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