Phase 3 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 their first local or regional return of breast cancer after completing treatment for the original breast cancer — this includes cancer returning in the same breast, the chest wall on the same side, or nearby lymph nodes.
• People where at least one returning tumour has been confirmed by biopsy or tissue sample, is invasive breast cancer (or was invasive at the time of original diagnosis if only a fluid cell sample is available), tests positive for hormone receptors, and tests negative for HER2. If any tested lesion is hormone receptor negative or HER2 positive, eligibility is affected.
• People with no prior diagnosis of breast cancer that has spread to distant parts of the body.
• People whose recent imaging shows no enlarged lymph nodes (10mm or more in short axis) and no signs of cancer spread to distant areas of the body.
• People aged 18 or older at the time of registration.
• People with an ECOG Performance Status of 0 or 1 — meaning fully active or able to carry out light activity (confirm with trial site if unsure about this score).
• People who have already received chemotherapy for the returning breast cancer may still be eligible.
• People who have cancer in one breast only, not both.
• People who have never previously been treated with a type of medication called CDK4/6 inhibitors.
• People who have provided written consent to participate in the trial.

Who may not be able to join:

• People who currently have another active cancer that requires treatment.
• People who have an ongoing infectious disease that requires systemic (whole-body) treatment.
• People who have a fever of 38.0°C or higher at the time of registration.
• Women who are pregnant, possibly pregnant, within 28 days of giving birth, or currently breastfeeding; also men whose partners are planning to become pregnant.
• People with a psychiatric illness or mental health symptoms that significantly affect daily life and could make trial participation difficult.
• People currently taking steroid medications (by mouth or intravenously) at a dose equivalent to 10mg or more per day of prednisolone, or taking other medicines that suppress the immune system.
• People who have experienced unstable chest pain (angina) that started or worsened in the past 3 weeks, or a heart attack in the past 6 months.
• People with high blood pressure that is not well controlled.
• People with diabetes that remains poorly controlled despite ongoing insulin or oral diabetes medication.
• People who test positive for hepatitis B surface antigen, or who test positive for hepatitis C antibodies and also have detectable hepatitis C virus in their blood (those who test positive for hepatitis C antibodies but have no detectable virus may still be eligible).
• People who test positive for HIV antibodies (note: HIV testing is not a required part of the trial process).
• People diagnosed with interstitial pneumonia, pulmonary fibrosis, or severe emphysema (serious lung conditions) identified on a chest CT scan.

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