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 been diagnosed with hormone receptor positive (the cancer is fuelled by oestrogen and/or progesterone), HER-2 negative breast cancer that has spread to other parts of the body (metastatic), and who are receiving or are about to start their first treatment aimed at the whole body for this stage of the disease.
• People whose metastatic breast cancer is either newly diagnosed at an advanced stage, or has returned and spread after being treated at an earlier stage.
• People who are registered to the first step of the trial no earlier than 14 days before, and no later than 60 days after, starting their first whole-body treatment for metastatic disease.
• People who have had specific blood tumour marker (STM) tests — CEA, and at least one of CA 15-3 or CA 27.29 — done after their metastatic diagnosis and within 14 days either side of starting treatment, with at least one result being 1.5 times or more above the normal upper limit for that laboratory.
• People who have had full-body imaging (such as a scan) before, or within 30 days of starting, their metastatic treatment and before entering the first step of the trial.
• People who are willing to have ongoing disease monitoring (scans and/or blood tumour marker tests) at a consistent facility whose results the registering site can access, for the full duration of the study (up to 312 weeks after the second step).
• People who are able to make their own decisions and can give written informed consent personally (a representative acting on the person's behalf is not permitted for this study).
• People who have had no other cancer history except breast cancer, with these exceptions: adequately treated basal or squamous cell skin cancer; any cancer from which the person has been disease-free for five years; or a previously removed pre-cancerous or Stage 0 lesion with clear margins.
• People who have not received any prior whole-body treatment for metastatic breast cancer other than their current treatment.
• People who are able to complete questionnaires in English or Spanish must take part in the patient-reported outcome assessments; those who cannot complete questionnaires in either language may still be eligible for the second step (confirm with trial site).
• People whose tumour marker results, tested again between 56 and 140 days after starting first-line treatment, show at least one previously elevated marker has dropped by 10% or more compared to the first test.
• People who show no signs of disease progression since entering the first step of the trial, at the time of entering the second step.
• People who complete baseline questionnaires within 28 days before the second-step randomisation.
• People whose treating institution has a current (within the past 365 days) ethics/institutional review board approval on record for this study.

Who may not be able to join:

• People who are pregnant, due to the radiation exposure involved in the required imaging.
• People with a known diagnosis of cirrhosis, untreated vitamin B12 deficiency, thalassemia, or sickle cell anaemia, as these conditions can cause falsely elevated tumour marker results.
• People who have known cancer spread to the membranes surrounding the brain or spinal cord (leptomeningeal metastases), as this may require its own regular scan monitoring.
• People who are currently enrolled in, or planning to join, another first-line metastatic breast cancer treatment trial that has its own set monitoring schedule.

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