Phase 2 Brain 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:

• Women aged 18 or older who have been diagnosed with a specific type of breast cancer confirmed by tissue testing (triple-negative breast cancer: ER less than 10%, PR less than 10%, HER2 negative), and who have not yet received any treatment for it
• People whose breast cancer shows a certain level of immune cell activity in the tumor (tumor infiltrating lymphocytes of 5% or more, as measured locally)
• People with early-stage breast cancer (stage I, specifically classified as cT1N0 based on imaging scans), with no signs that the cancer has spread to lymph nodes or other parts of the body
• People with tumors in both breasts, or multiple tumors in one breast, may be considered, as long as all required testing is done on the same target tumor
• People who are in good general health, able to carry out normal daily activities with little or no limitation (assessed using a standard health scale called ECOG, score of 0 or 1)
• People who are able to have children must have a negative pregnancy test before starting treatment, and must agree to use highly effective contraception (with a failure rate of less than 1% per year) plus a barrier method such as a condom, or to abstain from sexual activity, during the trial and for at least 3 months after the last dose of the study treatment
• People who are permanently unable to have children due to surgical procedures such as removal of the uterus, both ovaries, or both fallopian tubes are also considered eligible (confirm with trial site)
• People who are not breastfeeding and agree not to breastfeed during the trial and for at least 3 months after the last treatment dose
• People whose blood test results fall within acceptable ranges for kidney function, liver function, blood cell counts, blood proteins, and certain digestive enzymes (confirm specific values with trial site)
• People who are enrolled in a social security or equivalent health coverage system (specific to the country where the trial is conducted — confirm with trial site)
• People who understand and are willing to sign a consent form, provide tissue, blood, and stool samples as required, and attend all required study visits

Who may not be able to join:

• People whose triple-negative breast cancer has fewer than 5% immune cells (TILs) present in the tumor
• People who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy for their current breast cancer
• People with a known allergy or sensitivity to the study drug durvalumab or any of its ingredients
• People who have previously had a stem cell transplant from a donor or a solid organ transplant (such as a kidney or liver transplant)
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before joining, or who are expected to need one during the trial or within 5 months after the last dose of durvalumab
• People who have been treated with medications that stimulate the immune system (such as interferons or interleukin-2) within 4 weeks before joining
• People who have taken immune-suppressing medications (such as corticosteroids, methotrexate, or similar drugs) within 2 weeks before starting, or who are expected to need them during the trial — though some exceptions apply, including low-dose steroids, inhaled or topical steroids, and certain specific medical uses (confirm with trial site)
• People with an active autoimmune disease or immune deficiency condition — some exceptions may apply for people with treated underactive thyroid or type 1 diabetes managed with insulin (confirm with trial site)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, or interstitial lung disease
• People with a known HIV infection
• People with an active hepatitis B or hepatitis C infection — some exceptions may apply depending on test results (confirm with trial site)
• People with active tuberculosis
• People currently receiving antiviral treatment for hepatitis B
• People who are currently participating in, or have participated in, another clinical trial with an experimental treatment in the last 28 days
• People who have previously been treated with certain immune-related therapies, including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies, or CD137-activating treatments
• People whose personal, family, social, or geographic circumstances would make it difficult to follow the trial requirements
• People with serious uncontrolled medical conditions that would make treatment-related complications more likely
• People with significant heart conditions or recent cardiac events, including chest pain (angina), heart attack, or heart bypass surgery within the past 12 months; serious heart failure; cardiomyopathy; reduced heart pumping function (ejection fraction below 50%); certain abnormal heart rhythms in the past 12 months; uncontrolled high blood pressure; or conditions affecting the heart's electrical signals such as long QT syndrome (confirm full list of heart-related criteria with trial site)
• People who are pregnant or breastfeeding
• People who are unwilling or unable to follow the trial protocol as assessed by the trial team
• People who are under legal guardianship, detained by court or administrative decision, or who are not able to give informed consent

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