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:

• People diagnosed with triple-negative breast cancer (TNBC), meaning lab results show the cancer tests negative for HER-2 and has less than 10% expression of both estrogen and progesterone receptors.
• People whose cancer has continued to grow or spread after receiving at least one prior standard treatment (such as chemotherapy, immunotherapy, or certain targeted drug therapies), given alone or in combination.
• People who received treatment before or after surgery (neo-adjuvant or adjuvant therapy) must have finished that treatment at least one year before joining the trial.
• People aged 18 or older.
• People who are generally able to carry out normal daily activities, or who have some limitations but are still up and about for more than half of waking hours (this is measured using a standard medical scale called ECOG, scores 0 to 2).
• People expected to live at least 6 months.
• People whose recent blood and organ function tests meet specific minimum levels, including blood cell counts, kidney function, and liver function (the trial site can provide exact values).
• People who have at least one tumour that can be measured on a scan, with the largest tumour being at least 10 mm across (or at least 15 mm for affected lymph nodes).
• People with known cancer spread to the brain may be eligible if brain treatments have been completed, the condition has been stable with no new symptoms for at least one month, and steroid doses have been stable or are being carefully reduced (confirm with trial site).
• People who are willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
• People who are able to understand the trial and provide signed written consent before any trial procedures begin (a legally authorised representative may sign on behalf of the person if needed).
• Women who could become pregnant must have a negative pregnancy test within 24 hours before receiving the study drug.
• Women who could become pregnant must agree to use a highly effective form of contraception during the trial and for 12 months after receiving the study drug.
• Men who are able to father a child must agree to use a condom during the trial and for 12 months after receiving the study drug.

Who may not be able to join:

• People who have received anti-cancer or experimental treatments recently (within a timeframe based on how long the specific drug stays active in the body) before starting the study drug.
• People who have had a type of cancer treatment that uses targeted radiation therapy directed at specific tumours (confirm with trial site for exact definition).
• People who have previously received external beam radiation therapy that exposed more than 20% of their total bone marrow to a high radiation dose (confirm with trial site for details).
• People who are still experiencing side effects rated moderate or worse from previous treatments (with the exception of hair loss), where the treating doctor believes these could be made worse by the study treatment.
• People who have had, or currently have, another type of cancer in addition to TNBC, unless that other cancer has been fully treated with no signs of return for at least 2 years. Certain exceptions apply, including some skin cancers, early-stage melanoma, treated cervical changes, and successfully treated prostate cancer (confirm with trial site).
• People with other serious illnesses or problems with organ function, including heart or lung conditions, that the doctor believes could put the person at risk or affect how safely the study drug can be assessed.
• People with a known history of HIV, or who have an active, serious infection that is not under control.
• People who are pregnant or currently breastfeeding.

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