Phase 3 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 whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2).
• People diagnosed with Triple Negative Breast Cancer, meaning the cancer tested negative for estrogen receptors, progesterone receptors, and HER2, based on standard laboratory guidelines.
• People whose breast cancer was at a certain stage (clinical stage II or III) at the time of original diagnosis, based on tumour size and whether nearby lymph nodes were affected.
• People who had no remaining invasive cancer in the breast or lymph nodes after completing pre-surgery chemotherapy (a small amount of non-invasive cell changes called DCIS is still allowed).
• People who have cancer present in both breasts may still be considered, as long as both tumours meet the trial's requirements.
• People who received at least 6 cycles of chemotherapy combined with a drug called pembrolizumab before surgery, with all chemotherapy completed before the operation.
• People who had their final surgery no more than 12 weeks before joining the trial.
• People who had all visible cancer surgically removed from the breast and lymph nodes, meeting specific surgical requirements for clear margins (confirm with trial site for details).
• People who had breast-conserving surgery (keeping most of the breast) must be receiving radiation therapy to that breast to be considered.
• People who are not currently pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test within 7 days before joining.
• People whose blood cell counts and organ function results fall within the ranges required by the trial, based on recent blood tests.
• People who are willing to provide a tumour tissue sample from their original biopsy (those without enough tissue available may still be considered).
• People who have had or currently have another type of cancer may be considered, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People with a history of heart problems should have heart function assessed; those rated as class 2B or better on a standard heart health scale may be considered.
• People living with HIV who are on effective treatment and have had an undetectable level of virus in the blood within the past 6 months may be considered.

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (stage IV or metastatic disease).
• People who have a history of a previous invasive breast cancer in either breast (a prior non-invasive condition called DCIS is allowed).
• People who show signs that their cancer has come back after surgery and pre-surgery treatment.
• People with known active liver disease, such as hepatitis B, hepatitis C, autoimmune liver conditions, or a condition called sclerosing cholangitis.
• People who previously had a severe allergic or infusion reaction (grade 3 or 4) to pembrolizumab or similar medications; milder past side effects from pembrolizumab may be acceptable in certain circumstances (confirm with trial site).
• People who need to take steroid medications (more than 10 mg of prednisone daily or an equivalent dose) or other immune-suppressing medications on an ongoing basis, or who have needed such treatment in the last two years; standard hormone or gland replacement therapies are not considered immune-suppressing for this purpose.
• People who are unable or unwilling to follow the requirements of the trial, as assessed by the treating doctor.

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