Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer

Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is to assess preliminary evidence of clinical activity of leflunomide in these patient populations.

Trial Details

NCT ID
NCT04997993
Phase
PHASE1
Sponsor
Deborah Doroshow
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Leflunomide
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • A) Advanced or metastatic solid tumor with lack of PTEN expression as determined by immunohistochemistry. Lack of PTEN expression is defined as the…
  • B) Advanced or metastatic solid tumor with a deleterious somatic mutation in PTEN as determined by tissue or ctDNA testing in a CLIA laboratory and…
  • C) Advanced or metastatic HER2 negative breast cancer. Patients must have received ≤ 3 prior cytotoxic chemotherapies for metastatic disease (immun…
  • °Patients with known PTEN altered breast cancer may participate regardless of lines of prior therapy if they meet criteria A or B.

For full eligibility, visit ClinicalTrials.gov.

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