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 have given written consent to participate, as required by law and research regulations, before any trial procedures begin.
• People with a newly confirmed diagnosis of locally advanced, non-metastatic triple-negative breast cancer (TNBC) that has not been treated before, as defined by current specialist guidelines.
• People whose cancer falls within specific staging categories based on tumour size and lymph node involvement, with no spread to distant parts of the body (confirm with trial site for exact staging details).
• People with multiple tumour areas (multifocal or multicentric disease), provided all areas are confirmed as TNBC and the most advanced tumour is used to assess eligibility.
• People who have at least one measurable tumour in the breast that is 1.5 cm or larger, visible on ultrasound, and able to be injected.
• People aged 18 years or older, of any gender.
• People with a good general health status, able to carry out normal daily activities with little or no limitation (ECOG performance status 0–1).
• People whose bone marrow is functioning adequately, with sufficient levels of white blood cells, platelets, and haemoglobin, without having needed blood-boosting treatments or transfusions in the 14 days before registration.
• People whose liver is functioning adequately, based on specific blood test results within acceptable ranges (confirm with trial site for exact values).
• People whose kidneys are functioning adequately, based on a kidney filtration rate of 50 ml/min/1.73 m² or above.
• People whose heart is functioning adequately, with a heart pumping function (LVEF) of 50% or above, confirmed by an echocardiogram.
• People with adequate blood clotting function, or who are on blood-thinning medication that a treating doctor confirms can be safely stopped at least 24 hours before injections.
• Women who could become pregnant must use highly effective contraception, must not be pregnant or breastfeeding, must agree not to become pregnant during treatment and for 7 months after the last dose of the trial drug (or 6 months after standard treatment), and must have a negative pregnancy test before joining.
• Men must agree to use effective contraception and not donate sperm during treatment and for 6 months after the last dose of the trial drug or standard treatment.

Who may not be able to join:

• People with inflammatory breast cancer (a specific type classified as cT4d).
• People where the treating doctor, surgeon, or investigator determines that the relationship between tumour size and breast size means shrinkage from pre-surgery treatment would be needed before breast-conserving surgery could be considered.
• People where the tumour is located in a position that could lead to a poor cosmetic result or involves close contact with the skin, as judged by the treating doctor, surgeon, or investigator.
• People whose TNBC is of certain less common subtypes, including classic adenoid cystic carcinoma, secretory carcinoma, low-grade adenosquamous carcinoma, tall cell carcinoma with reversed polarity, or high-grade metaplastic carcinoma.
• People who have had another invasive cancer within the past 3 years, with the exception of treated basal cell or squamous cell skin cancer, or cervical cancer that had not spread.
• People who have previously received chemotherapy, targeted therapy, radiation therapy, or anti-PD-L1 treatment for breast cancer or a pre-cancerous breast condition (DCIS) on the same side.
• People who currently have cancer in both breasts at the same time.
• People who are already taking part in another clinical trial involving an experimental drug for their recent breast cancer diagnosis.
• People with serious or uncontrolled heart conditions, including certain types of heart failure, unstable chest pain, a recent heart attack or major heart procedure within the last six months, certain serious heart rhythm problems, significant abnormalities in heart electrical activity, or uncontrolled high blood pressure.
• People with a known history of HIV, or active hepatitis B or C infection, or any uncontrolled active infection requiring intravenous antibiotics or antiviral treatment.
• People with an active autoimmune disease that required systemic (whole-body) treatment within the past 2 years — note that standard hormone or gland replacement therapies are not considered systemic treatment for this purpose.
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with a known history of tuberculosis.
• People with a known history of receiving an organ or stem cell transplant from another person.
• People who have received a live vaccine (including yellow fever vaccine) within 30 days before registration.
• People with a diagnosis of immune deficiency, or who have taken immune-suppressing medication within 7 days before registration — with limited exceptions for low-dose local or inhaled steroids and pre-chemotherapy medications (confirm with trial site for details).
• People taking certain blood-thinning medications, including warfarin, certain factor Xa inhibitors, direct thrombin inhibitors, or antiplatelet agents, if those medications cannot be stopped 24 hours before the trial drug injection. (Aspirin up to 300 mg/day is permitted.)
• People taking any other medications that are listed as incompatible with the trial drug or the immunotherapy-chemotherapy treatment.
• People with a known allergy or sensitivity to the trial drug or any of its components, or to the immunotherapy-chemotherapy treatment.
• People who are unable to make their own decisions, or who have serious medical, psychiatric, psychological, family, or geographic circumstances that the investigator believes could interfere with treatment, follow-up, or safety.

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