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 who have been confirmed by laboratory testing to have Triple Negative Breast Cancer (TNBC) — meaning the cancer tests negative for estrogen receptors, progesterone receptors, and HER2 — with some exceptions allowed if the treating doctor determines certain borderline results do not warrant hormone or HER2-targeted treatment.
• People whose cancer is at an early stage (Stage 1, specifically T1b or T1c, with no spread to lymph nodes or other parts of the body); people with suspicious lymph nodes may still be eligible if a biopsy of those nodes comes back negative.
• People whose previous cancer treatment side effects have mostly resolved (back to mild or baseline levels), or who have mild nerve-related side effects (Grade 2 or lower).
• People who are well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, scored 0 or 1), assessed within 7 days before starting the study treatment.
• People whose blood, kidney, liver, and clotting functions meet the minimum levels required by the trial, tested within 10 days before starting treatment.
• People who are able to provide a sample of tumour tissue (either archived or newly collected from a site that has not been previously treated with radiation).
• People who speak a language for which a licensed interpreter can be provided (in person or virtually), so non-English speakers may also be eligible.
• People living with HIV may be eligible if their HIV is well-controlled, viral load is undetectable on antiviral medication, and they have had no serious HIV-related infections in the past 12 months.
• People with a history of Hepatitis B may be eligible if they have been on antiviral treatment for at least 4 weeks and have an undetectable viral load before joining the trial.
• People with a history of Hepatitis C may be eligible if the virus is undetectable and they have completed curative antiviral treatment at least 4 weeks before joining the trial.
• Male participants must agree to use contraception during treatment and for at least 120 days after the last dose, and must not donate sperm during this period.
• Female participants must not be pregnant or breastfeeding, and must either not be of childbearing potential or must agree to use contraception during treatment and for at least 120 days after the last dose.

Who may not be able to join:

• People whose breast cancer is at Stage 2, 3, or 4.
• People whose breast cancer tests positive for hormone receptors (oestrogen or progesterone) or HER2.
• People who have previously been treated with certain immunotherapy drugs that target the immune system's "checkpoint" pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar therapies targeting CTLA-4, OX-40, or CD137).
• People who have received any systemic cancer treatment (including experimental treatments) within the past 4 weeks.
• People who have had radiotherapy within the past 2 weeks before starting the trial, or who have ongoing side effects from radiation that require steroid treatment.
• People who have received a live or live-attenuated vaccine within the 30 days before the first dose (non-live/killed vaccines are permitted).
• People who have used an experimental drug or device within the past 4 weeks.
• People with a known immune system deficiency, or who are currently taking immune-suppressing medications (including steroids above a certain dose) within 7 days before starting the trial.
• People who have had another cancer that is still active or has required treatment within the past 3 years (some exceptions apply for certain treated skin cancers).
• People with active cancer that has spread to the brain or the lining of the brain or spinal cord.
• People with a history of severe allergic reactions to any of the study drugs or their ingredients.
• People with an active autoimmune disease that has needed systemic (whole-body) treatment in the past 2 years (routine hormone replacement such as thyroid medication or insulin is not excluded).
• People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People with an active infection requiring systemic treatment for more than 14 days from the start of the trial treatment.
• People who have both active Hepatitis B and active Hepatitis C infections at the same time.
• People who have not fully recovered from major surgery, or who have ongoing complications from surgery.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period and up to 120 days after the last dose.
• People who have previously received an organ or tissue transplant from another person.
• People with certain heart conditions that make the chemotherapy drug doxorubicin unsafe for them (such as recent heart attack, severe heart failure, severe irregular heartbeat, or having already received the maximum lifetime dose of certain chemotherapy drugs in the same family).
• Women of childbearing potential who have a positive pregnancy test within 72 hours before the first dose.

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