Study on Leflunomide for Previously Treated Metastatic Triple Negative Breast Cancer

Sponsor: Joseph Sparano

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03709446

Provider View

This clinical trial is testing the safety and effectiveness of a drug called leflunomide for women with metastatic triple negative breast cancer (TNBC) that has already been treated with other therapies. The study aims to find out if leflunomide can help control this aggressive type of breast cancer.

Patient Parameters

Program Overview

Triple negative breast cancer (TNBC) is a type of breast cancer that does not have the usual hormone receptors or HER-2 protein. It often affects younger women, African American women, and those with a BRCA-1 gene mutation. TNBC tends to spread quickly, and once it becomes metastatic, the outlook is poor, with survival typically around one year. This study is exploring whether leflunomide, a drug taken daily by mouth, can be a new treatment option for women with metastatic TNBC. The study will first determine the safest dose of leflunomide and then evaluate how well it works in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Women with confirmed HER2-negative metastatic or advanced breast cancer that cannot be surgically removed.
  • Aged 18 or older.
  • Have had up to 3 prior chemotherapy treatments for metastatic cancer and up to 2 prior antibody drug treatments.
  • For ER-positive breast cancer, must have had disease progression after certain treatments.
  • Previous immunotherapy is allowed.
  • Can use bone-strengthening medications like denosumab or zoledronic acid.
  • If brain metastases were treated, must be stable for at least 4 weeks without steroids.
  • At least 4 weeks since last cancer treatment or surgery.
  • Good overall health with a performance status of 0-2.
  • Adequate blood cell counts and organ function.
  • Negative pregnancy test for women of childbearing potential.
  • Agree to use effective birth control during and after the study.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Recent chemotherapy or radiation within 2 weeks before the study.
  • Currently taking other experimental drugs.
  • History of HIV, hepatitis B or C, or tuberculosis.
  • Untreated brain metastases.
  • Allergic reactions to leflunomide or similar drugs.
  • Uncontrolled illnesses like infections, heart failure, or psychiatric conditions.
  • Pregnant or breastfeeding women.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.