Phase 2 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 have been diagnosed with metastatic triple negative breast cancer (a specific type of breast cancer that has spread), confirmed by a lab test, and have already received at least 2 rounds of treatment for the metastatic disease.
• Your tumor has been tested and found to have a specific change in a gene called TP53, confirmed by an approved lab test.
• Your tumor has been tested and shown to be low or negative for estrogen receptor (ER) and negative for progesterone receptor (PgR), according to standard testing guidelines.
• Your tumor has tested negative for a protein called HER-2, confirmed by standard lab tests.
• You are 18 years of age or older.
• You are generally well enough to carry out everyday activities with little or no limitation (confirmed by a standard medical assessment called ECOG performance status 0–1).
• Your blood test results meet specific levels: enough white blood cells, red blood cells (hemoglobin at least 9 g/dL), and platelets.
• Your liver function blood test results are within acceptable ranges.
• Your kidneys are working well enough (confirmed with a blood or urine test).
• A heart scan done within 30 days before joining shows your heart is pumping at 50% or more of its normal capacity.
• You are able to swallow tablets or capsules by mouth.
• If you are able to become pregnant, you agree to use effective birth control during the study, and you will notify your doctor right away if you become pregnant.
• You understand the study is investigational and have signed a written consent form before any study procedures begin.

Who may not be able to join:

• You have a medical reason that makes hormone-based therapy unsafe for you, in your doctor's opinion.
• You have received chemotherapy, hormone therapy, immunotherapy, radiation, or any other cancer treatment within the last 4 weeks (or 6 weeks for certain specific drugs), or you are still experiencing side effects from a previous treatment.
• You have had a serious allergic reaction to tamoxifen or a similar drug in the past.
• You have a known history of blood clotting problems, or have previously had a blood clot, stroke, mini-stroke (TIA), or a blood clot in the lungs.
• You are known to be HIV positive or have an AIDS-related illness.
• You have a history of or currently have significant heart problems, such as chest pain (angina), certain irregular heartbeats, a previous heart attack, heart failure, or a weakened heart muscle.
• You have severe liver disease or cirrhosis.
• You have an ongoing serious infection requiring treatment (other than a simple urinary tract infection), or a mental health or personal situation that would make it difficult to follow the study requirements.
• You are currently pregnant or breastfeeding.
• You are unwilling or unable to follow the study's requirements.
• Your doctor believes for any other reason that this study would not be appropriate for you.

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