Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be 18 years of age or older.
• You have an advanced or spreading solid tumor cancer where a specific protein called PTEN is missing, as shown by a special lab test on tumor tissue.
• You have an advanced or spreading solid tumor cancer where a harmful change (mutation) in the PTEN gene has been found through a certified lab test on tissue or blood.
• You have advanced or spreading HER2-negative breast cancer, have received no more than 3 prior chemotherapy treatments for metastatic disease, and have previously tried certain other required treatments (confirm with trial site for full details).
• Your cancer must have gotten worse on, or you were unable to tolerate, the standard available treatments for your cancer type.
• You have measurable tumors that can be tracked on scans (required for certain parts of the trial — confirm with trial site).
• If you have prostate cancer without measurable tumors, you must have a detectable PSA level in your blood.
• If you had brain tumors that were previously treated, follow-up brain scans at least 4 weeks after treatment must show they have not grown.
• If you have new or growing brain tumors, your doctor has decided that immediate brain-directed treatment is not needed right now (confirm with trial site).
• At least 2 weeks (or five half-lives of the drug, whichever is shorter) must have passed since your last cancer treatment, surgery, or radiation.
• You are generally well enough to carry out daily activities, rated 0–2 on a standard medical fitness scale (confirm with trial site).
• If you have HIV, you must be on effective treatment with an undetectable level of virus in your blood.
• Your blood counts, liver, and kidney function must meet certain minimum levels as measured by blood tests (confirm with trial site for specific numbers).
• If you could become pregnant, you must have a negative pregnancy test within 3 days before starting the study drug.
• You and your partner must agree to use reliable birth control during the study and for 90 days after finishing treatment.
• If you are a woman who could become pregnant and you stop taking the study drug for any reason, you must either follow a specific elimination process or use birth control for up to 2 years afterward.
• You must be able to understand the study and be willing to sign a consent form agreeing to take part.

Who may not be able to join:

• You have a cancer that started in the brain or spinal cord (primary brain tumor).
• You had chemotherapy or radiation within the last 4 weeks, or you are still experiencing significant side effects (grade 2 or higher) from earlier treatments (some side effects like hair loss or nerve problems may be allowed — confirm with trial site).
• You are currently taking part in another clinical trial using an experimental treatment.
• You have a known history of Hepatitis B or Hepatitis C, either past or ongoing.
• You have had a serious allergic reaction to a drug that is chemically similar to leflunomide or teriflunomide (the study drugs).
• You have an uncontrolled ongoing illness, such as an active serious infection, unstable heart condition, uncontrolled heart rhythm problems, or a mental health or personal situation that would make it hard to follow the study requirements.
• You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.