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 70 years old.
• People who have been diagnosed with invasive breast cancer confirmed by a tissue biopsy, specifically Stage II or Stage III triple-negative breast cancer (a type of breast cancer that lacks three common receptors).
• People whose cancer has at least one tumour that can be measured using standard imaging guidelines.
• People who have not previously received chemotherapy, immunotherapy, hormone therapy, major surgery, or radiotherapy for their breast cancer.
• People who are generally well enough to carry out light activity and care for themselves (a standard doctor-assessed fitness rating of 0 or 1).
• People whose blood counts, liver function, kidney function, and lung imaging fall within acceptable ranges as determined by the trial site.
• People with a healthy heart, including normal heart rhythm, normal pumping function (55% or above on an ultrasound), and normal heart-related blood markers.
• People with normal thyroid hormone levels.
• People who are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

• Men, or people diagnosed with inflammatory breast cancer.
• People whose breast cancer has spread to other parts of the body (Stage IV).
• People who have had an active autoimmune or inflammatory condition (such as lupus, rheumatoid arthritis, inflammatory bowel disease, or similar) that required ongoing medical treatment within the past two years — though some exceptions may apply, such as well-controlled thyroid conditions or type 1 diabetes (confirm with trial site).
• People who currently have, or have had within the past five years, another type of cancer — with possible exceptions for certain treated skin cancers or early-stage cervical changes (confirm with trial site).
• People with another serious illness that could affect their ability to safely participate.
• People who have had major surgery within the four weeks before the trial starts, or who are expected to need major surgery during the trial.
• People who have already received any treatment for their breast cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, or hormone therapy.
• People who are known to have an allergy or sensitivity to any ingredient in the trial medications.
• People with poorly controlled heart disease, such as significant heart failure, unstable chest pain, a heart attack within the past year, or serious heart rhythm problems needing treatment.
• People who have a history of scarring or inflammation of the lungs (interstitial lung disease), currently have it, or show signs of it on imaging during screening.
• People with active infections including HIV, active tuberculosis, active hepatitis B, or active hepatitis C.
• People with an active autoimmune disease that currently requires ongoing medical treatment.
• People with dementia, significant cognitive difficulties, or a psychiatric condition that would make it difficult to understand and sign a consent form.
• People with wounds, ulcers, or fractures that have not healed in the four weeks before signing consent, or people with a history of significant bleeding problems.
• People who the trial doctor considers unsuitable for participation for any other reason.

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