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:

• People aged 18 or older.
• People who have been diagnosed with triple negative breast cancer, meaning the cancer cells test low (10% or less) for estrogen and progesterone receptors on lab testing.
• People whose breast cancer diagnosis has been confirmed by a tissue sample from outside the brain, and who have cancer that has spread to the brain, confirmed by MRI or brain surgery pathology.
• People whose brain metastases are suitable for a type of targeted radiation treatment called stereotactic radiosurgery (SRS) (confirm with trial site).
• People who have at least one measurable area of cancer in the brain that is 0.5 cm or larger.
• People whose largest brain metastasis measures 4 cm or less across.
• People with a general health status rated as reasonably functional, on a scale from 0 (fully active) to 2 (limited in strenuous activity but able to carry out light work) — known as ECOG performance status 0 to 2.
• People who have already had cancer-related brain surgery or who are taking a stable, low dose of steroids (no more than 8 mg per day of dexamethasone) for symptoms.
• People who have previously been treated with specific chemotherapy types called taxanes and anthracyclines.
• People who have previously received certain types of radiation to the brain, provided the areas of active, measurable disease being studied have not already been treated with radiation.
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 24 hours before each dose of the study drug.
• Men and women of childbearing potential who are sexually active with a partner of the opposite sex must agree to use specified methods of contraception during the study.
• People who have signed and dated a consent form agreeing to take part and follow all study procedures for the full duration of the trial.

Who may not be able to join:

• People whose cancer has spread to the lining of the brain or spinal cord (leptomeningeal disease).
• People who are pregnant or currently breastfeeding.
• People with a known history of HIV (type 1 or 2) where the virus is still detectable in the blood.
• People with an active, known, or suspected autoimmune disease, or those who need immunosuppressive treatment for a nerve or muscle condition related to their cancer. Exceptions may apply for people with type 1 diabetes, an underactive thyroid managed with hormone replacement, certain skin conditions not needing systemic treatment (such as vitiligo, psoriasis, or alopecia), or conditions not expected to return without an external trigger (confirm with trial site).
• People who have had lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease) that required steroid treatment, or who currently have these conditions.
• People who have had any of the following heart-related conditions: a heart attack or unstable chest pain within the past 6 months; a history of serious heart rhythm problems or a history of prolonged QT interval (an electrical timing problem in the heart); moderate to severe heart failure or a significantly reduced heart pumping function; or certain heart rhythm conditions requiring medication (except well-controlled atrial fibrillation).
• People who need extra oxygen to breathe.
• People who have a serious active infection currently being treated with antibiotics.
• People with active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or those who have had a bowel perforation within the past 6 months.
• People with a history of cancers other than breast cancer, unless the other cancer was adequately treated skin cancer (basal cell or squamous cell), chronic lymphocytic leukaemia, or another cancer that has been in remission without active treatment for 2 or more years.
• People with a known medical condition that, in the opinion of the study doctor, would increase the risks of participating or interfere with understanding the safety results.
• People who have had major surgery or a significant injury and have not fully recovered at least 14 days before starting the study drug.
• People who have received a biological cancer treatment within the past 4 weeks, or chemotherapy or targeted therapy within the past 2 weeks and have not yet recovered from side effects.
• People who have previously received a type of chemotherapy called a topoisomerase 1 inhibitor specifically to treat brain metastases.
• People who have taken another experimental (unapproved) drug within 28 days or 5 half-lives of the drug (whichever is longer) before the first dose of the study drug.
• People with active Hepatitis B or Hepatitis C infection, or a history of either where the virus is still detectable in the blood.
• People with a known allergy or serious reaction to any of the study drugs or their ingredients.
• People who are in prison or held in a facility against their will.
• People who are being held involuntarily for treatment of a mental health or physical health condition.

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