A randomized, 2-arm, open-label, phase II study of abemaciclib combined with endocrine therapy (letrozole or fulvestrant) with or without a short course of induction chemotherapy with paclitaxel as first-line therapy in patients with unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer with aggressive disease criteria. (ABIGAIL)

To be able to take part in this study, you would generally need to meet specific criteria. The study welcomes both men and women.

You must be at least 18 years old. There isn't an upper age limit mentioned, which means older adults might also be eligible. The study is specifically for people diagnosed with breast cancer that is advanced, meaning it has either spread to nearby areas and can't be removed with surgery, or it has spread to other parts of the body (metastatic).

Crucially, your breast cancer must be 'HR-positive' (meaning it responds to hormones) and 'HER2-negative' (meaning it doesn't have an excess of the HER2 protein). These are important details that your doctor can confirm from your cancer test results.

If you decide to take part in this study, you'll be assigned to one of two treatment groups. Both groups will involve taking certain medications, some by mouth and some by injection or infusion (into a vein). One group will receive a short initial course of chemotherapy (paclitaxel) in addition to other drugs. Throughout the study, you'll have regular appointments at the hospital or clinic. These visits will involve various assessments, such as physical exams, blood tests, and scans (like CT or MRI scans) to see how the cancer is responding to the treatment. These tests help the doctors measure the size of your tumours and track their progress. The main aim is to see how the treatment affects your cancer within the first 12 weeks, but the study will continue to monitor your progress for a longer period. The total length of your participation will depend on how your treatment is going and what your doctors decide is best for you.