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:

• Women aged 18 to 75 who have been newly diagnosed with breast cancer.
• People with early or locally advanced breast cancer confirmed by tissue testing to be "triple-negative" (meaning the tumour does not have HER2, oestrogen, or progesterone receptors).
• People whose cancer is classified as stage II or III.
• People who are generally well enough to carry out light activity and care for themselves (a standard health performance measure rated 0 or 1 out of 5).
• People with a life expectancy of at least 3 months.
• People whose cancer includes at least one measurable area of disease on scans, according to standard measurement guidelines.
• People with adequate blood counts and organ function, as assessed by the trial team.
• People who are willing to use an effective method of contraception throughout the trial.

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (stage IV / metastatic), or who have cancer in both breasts.
• People diagnosed with inflammatory breast cancer.
• People who have received any anti-cancer treatment in the past 12 months, including chemotherapy, targeted therapy, radiation, immunotherapy, biological therapy, or a procedure called TAE.
• People who have previously been treated with certain types of immunotherapy drugs that target PD-1, PD-L1, PD-L2, CTLA-4, or anti-VEGFR pathways.
• People who have had another invasive cancer within the last 5 years, with the exception of certain treated skin cancers or cervical changes that have not spread.
• People who have had a major surgical procedure within 4 weeks before the trial treatment is due to start.
• People with a history of autoimmune disease.
• People with high blood pressure that is not well controlled despite medication.
• People who, within the past 6 months, have had a heart attack, severe chest pain (unstable angina), significant heart rhythm problems, or moderate-to-severe heart failure.
• People with a history of non-infectious lung inflammation (pneumonitis), interstitial lung disease, or other serious uncontrolled systemic illnesses.
• People who have received a live vaccine within 28 days before the trial treatment starts, or who are expected to need one during the trial.
• People with a known history of HIV.
• People with active Hepatitis B, Hepatitis C, or autoimmune hepatitis.
• People who have had a serious infection requiring hospitalisation within 4 weeks before the trial treatment starts.
• People who have had an active infection requiring antibiotic treatment within 2 weeks before the trial treatment starts.
• People with evidence of active tuberculosis within the past year.
• People who have previously had a stem cell or organ transplant from another person.
• People with moderate or severe nerve damage in the hands or feet (peripheral neuropathy grade 2 or above).
• People with a clinically significant bowel obstruction.
• People who have had a blood clot, stroke, deep vein thrombosis, or pulmonary embolism within the 3 months before joining.
• People who have been coughing up blood within the 2 months before joining, particularly if the amount was 2.5 ml or more per day.
• People who have had significant bleeding, or a clear tendency to bleed, within the 3 months before joining.
• People with a known inherited or acquired tendency toward bleeding or blood clotting problems.
• People with abnormal blood clotting results, who are on clot-dissolving or blood-thinning medication, or who need long-term antiplatelet therapy.
• People with a known allergy or sensitivity to any component of the trial treatment, or a history of serious reactions to similar types of laboratory-made antibody treatments.
• People who are pregnant or breastfeeding, or women of childbearing age who test positive for pregnancy at the start of the trial, or who are unwilling to use effective contraception throughout.
• People with a history of neurological or psychiatric conditions, including epilepsy or dementia.
• Anyone the trial researchers assess as unsuitable for other reasons (confirm with trial site).

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