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 who are able to understand and follow instructions throughout the trial.
• People who are willing and able to sign a written consent form.
• People of any gender, aged 18 or older at the time of signing the consent form.
• People diagnosed with stage II or III triple-negative breast cancer (a specific type of breast cancer) who have been identified as candidates for a treatment plan combining an immune checkpoint drug (anti-PD1 antibody) with standard chemotherapy before surgery.
• People whose tumor can be accessed for biopsy and surgery, and where the biopsy shows at least 30% cancer cells.
• People with adequate bone marrow function, shown by blood test results meeting specific minimum levels for white blood cells, platelets, and hemoglobin (confirm with trial site for exact values).
• People with a blood clotting measurement (INR) within an acceptable range; people taking blood thinners called vitamin K antagonists may still be considered if their INR is below a certain level (confirm with trial site).
• People with adequate liver function, shown by liver enzyme and bilirubin blood test results within acceptable ranges; people with a condition called Gilbert disease may still be considered (confirm with trial site).
• People with adequate kidney function, based on a standard kidney function calculation using a blood test result.
• People who are able to undergo MRI or ultrasound scans to monitor the tumor during the trial.
• People with a general health and activity level rated at 2 or below on a standard medical scale (meaning they are able to carry out basic self-care, even if not able to do strenuous activity).
• People expected to live at least 12 months, based on the treating doctor's assessment.

Who may not be able to join:

• People with a history of any disease or health condition that the doctor believes could make the trial treatment unsafe or affect the trial results.
• People with serious side effects or complications from a previous treatment (rated grade 3 or higher on a standard medical scale) that have not improved to a mild level within 6 weeks before the trial starts.
• People with other significant health conditions that, in the doctor's opinion, make it unlikely they could follow the trial requirements.
• People who have had another cancer in the past 5 years, with some exceptions for certain early-stage or skin cancers, or cancers where full remission was achieved at least 2 years before screening (confirm with trial site).
• People who have previously had an organ transplant, including a bone marrow or stem cell transplant.
• People with a condition where the immune system does not work properly from birth or another cause, or with an active autoimmune disease that could worsen with immune-stimulating treatment — with some exceptions for mild conditions like vitiligo or psoriasis not requiring immune-suppressing medication (confirm with trial site).
• People with uncontrolled high blood pressure that has not responded to combination medication.
• People with a known serious allergic reaction or other contraindication to any of the trial drugs or their ingredients, including severe reactions to antibody-based medicines.
• People with certain serious ongoing medical conditions, including immune-related bowel inflammation, severe persistent vomiting or diarrhea, immune-related lung inflammation, lung scarring, or significant psychiatric conditions including recent or active thoughts of suicide.
• People who have had surgery to remove part of the small intestine or other major bowel surgery.
• People with an active infection that requires antibiotic treatment at the time of screening or at the start of the trial.
• People with a known history of HIV, AIDS, or multi-drug resistant bacterial infections.
• People with active hepatitis B or hepatitis C virus infection detected at screening.
• People who are considered to be at increased risk from general anaesthesia, for example due to airway difficulties, if general anaesthesia is required.
• People with an increased risk of bleeding, such as blood clotting disorders, or people currently taking blood-thinning medications.
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not willing to use a highly effective method of contraception during the trial period (confirm with trial site for the full list of accepted methods).
• Men who could father a child and are not willing to use highly effective contraception during the trial and for at least 30 days after the last dose of trial medication.
• People with a known history of drug or substance misuse.
• People who have received a live vaccine within the 30 days before starting trial treatment.
• People who are currently participating in another clinical trial or have done so within 30 days before screening.
• People receiving any other treatment that, in the doctor's opinion, could interfere with this trial.
• People currently misusing drugs or substances.
• People taking ongoing medications within 2 weeks before the trial that could interfere, including high-dose corticosteroids, immune-suppressing drugs, antibiotics, or any other cancer treatments not part of the standard treatment plan used in this trial.
• People who are unable to understand or are unlikely to follow the trial's requirements and attend follow-up visits.
• People who do not have the legal capacity to consent to participation.
• People who, in the doctor's opinion, face an unacceptable level of personal risk by taking part.

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