Clin2
NCT04997993Possibly a fitRecruiting

Leflunomide for PTEN-altered or HER2-negative metastatic cancers

PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer

Treatments studied

Part of Cancer clinical trials.

This Phase 1 trial studies whether leflunomide can slow or control advanced (metastatic) cancers in people whose tumors have specific PTEN changes or who have HER2-negative breast cancer. It’s primarily a safety-and-dosing study, but it may offer benefit if your cancer matches the tumor marker requirements.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
23 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You are age 18 or older and have an advanced or metastatic solid cancer (or HER2-negative breast cancer).
  • Your tumor must match one of these: missing PTEN on a specific lab test, a harmful PTEN mutation on approved genetic testing, or HER2-negative breast cancer with specific prior treatments.
  • You’ve already tried standard treatments for your cancer (if standard treatment exists), and your cancer is progressing, resistant, or you can’t tolerate it.
  • You must be able to take a washout period after your last chemo, radiation, surgery, or other major cancer treatment (typically about 2 weeks or 5 half-lives, whichever is shorter).
  • Your body/lab tests must be strong enough (blood counts, liver tests, and kidney function) and your health status must be good (ECOG 0–2).
  • You cannot be pregnant or nursing, and you must use reliable contraception during the study and for a period after; women must also follow an “elimination” plan after stopping the drug.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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