Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 years or older
• People diagnosed with a specific type of breast cancer called triple-negative breast cancer (TNBC), confirmed by a tissue test, that is either locally advanced (not able to be fully removed or treated with local therapy) or has spread to other parts of the body
• People whose cancer has continued to grow or spread after at least one previous treatment for advanced or metastatic TNBC
• People who have at least one tumour that can be measured on a scan, following specific size guidelines, and that has not previously been treated with radiotherapy
• People whose major organs (such as blood, liver, and kidneys) are functioning within acceptable ranges based on blood and biochemical tests
• People who have not received radiotherapy, targeted therapy, or surgery in the 3 weeks before the study starts, and whose side effects from previous treatments have settled (and whose wound has fully healed if surgery was performed); no nerve damage in the hands or feet, or only very mild nerve-related side effects
• People with a general health score showing they are either fully active or have only minor limitations in physical activity, and who are expected to live at least 3 months
• Women who are able to become pregnant and agree to use a medically approved method of contraception during treatment and for at least 3 months after the last dose of the study drug
• People who have voluntarily agreed to take part, signed a consent form, and are willing to follow the study requirements and attend follow-up visits

Who may not be able to join:

• People who have received radiotherapy (other than for pain relief), chemotherapy, or immunotherapy within the 3 weeks before starting treatment (bone-strengthening medications called bisphosphonates are an exception and may still be used)
• People with cancer that has spread to the brain or spinal fluid and is not under control, particularly if it is causing symptoms or requires medications such as steroids or mannitol to manage
• People with a significant or uncontrolled heart condition in the past 6 months, including heart failure, chest pain (angina), heart attack, or serious irregular heartbeat
• People who still have ongoing side effects rated grade 1 or higher from previous treatments, unless it is hair loss or another issue the research team determines should not be a reason for exclusion (confirm with trial site)
• People who have had major surgery within 3 weeks before the first treatment in the trial (minor procedures such as fitting a port or line for medication are generally not included in this)
• People who are pregnant or currently breastfeeding
• People who have had another cancer in the past 5 years, with the exception of certain skin cancers (basal cell carcinoma that has been fully treated) or early-stage cervical changes (cervical carcinoma in situ)

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